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1.  Racial Disparities in the Use of Revascularization Before Leg Amputation in Medicare Patients 
Black patients with peripheral arterial disease undergo amputation at two to four times the rate of white patients. In order to determine whether differences in attempts at limb salvage might contribute to this disparity, we studied the limb care received prior to amputation by black patients compared to whites.
Using inpatient Medicare data for years 2003-2006, we identified a retrospective sample of all beneficiaries who underwent major lower extremity amputation. ‘Limb salvage care’ was defined as limb-related admissions and procedures that occurred during the two years prior to amputation. We used multiple logistic regression to compare rates of revascularization and other limb care received by black versus white amputees, adjusting for individual patient characteristics. We then controlled for hospital referral region in order to assess whether differences in care might be attributable to the geographic regions in which black and white patients received care. Finally, we examined the timing of revascularization relative to amputation for both races.
Our sample included 24,600 black and 65,881 white amputees. Compared with whites, black amputees were more likely to be female and had lower socioeconomic status. Average age, rates of diabetes, and levels of comorbidity were similar between races. Black amputees were significantly less likely than whites to have undergone revascularization (23.6 vs. 31.6%, p<0.0001), any limb-related admission (39.6 vs. 44.7%, p<0.0001), toe amputation (12.9 vs. 13.8%, p<0.0005) or wound debridement (11.6 vs. 14.2%, p<0.0001) prior to amputation. After adjusting for differences in individual patient characteristics, black amputees remained significantly less likely than whites to undergo revascularization (OR 0.72 [95% confidence interval 0.68-0.76]), limb-related admission (OR 0.81 [0.78-0.84]), or wound debridement prior to amputation (OR 0.80 [0.75-0.85]). Timing of revascularization relative to amputation was similar between races. Observed differences in care were shown to exist within hospital referral regions, and were not accounted for by regional differences in where black and white patients received care.
Black patients are much less likely than whites to undergo attempts at limb salvage prior to amputation. Further studies should explore whether this disparity might be attributable to race-related differences in severity of arterial disease, patient preferences, or physician decision-making.
PMCID: PMC3152619  PMID: 21571495
2.  Critical limb ischaemia in a diabetic population from an Asian Centre: angiographic pattern of disease and 3-year limb salvage rate with percutaneous angioplasty as first line of treatment 
Lower extremity amputation prevention (LEAP) is an ongoing program in our institution aimed at salvaging limbs in patients with critical limb ischemia (CLI). Patients in the LEAP program with reconstructible anatomy on initial Doppler imaging received either bypass surgery or percutaneous transluminal balloon angioplasty (PTA). We present the 3 year limb salvage rate and angiographic disease patterns in 42 consecutive diabetic patients with CLI who received PTA in 2005.
Methods and Material:
26 women and 16 men with diabetes between the ages of 45 and 91 years old (mean age, 70.8 years) received PTA in 2005. Presenting symptoms were rest pain (n = 22), pre-existing gangrene (n = 17), non-healing ulcer (n = 16) and cellulitis (n = 2). The aim of the PTA was to achieve straight-line flow from the abdominal aorta down to the patent dorsalis pedis or plantar arch, with limb salvage as the ultimate outcome. Failure of treatment was defined as any amputation above the level of a Syme’s amputation or the need for further surgical bypass. Technical success was achieved in 90% (38 out of 42 patients).
Limb salvage rates were 93% at 1 month, 87% at 3 months, 82% at 6 months, 78% at 1 year, 69% at 2 years and 66% at 3 years. Mortality was 17% (n = 7) at 3 years. Of the 13 patients with failed therapy, 3 underwent bypass, 9 had amputations and 1 had bypass followed by amputation. Four of the cases required further intervention due to worsening gangrene and infection, while the remaining was due to persistent rest pain. The rest of the 32 patients had no lower limb related issues at the end of 3 years, with improvement of the presenting symptoms. Patterns of treated segments were aortoiliac occlusions (n = 3), pure infrapopliteal disease (n = 3), femoropopliteal with at least 1 good infrapopliteal run-off vessel (n = 14) and combined femoropopliteal and infrapopliteal disease (n = 25).
Involvement of infrapopliteal vessels that needs to be treated is common in Asian diabetics. While early limb salvage rates up to 1 year are similar, the 3 year limb salvage rates in Asian diabetics are lower than the western population.
PMCID: PMC3097802  PMID: 21611069
Limb salvage rate; lower limb vascular disease pattern; diabetics; Asian centre; percutaneous angioplasty
3.  Major limb amputations: A tertiary hospital experience in northwestern Tanzania 
Major limb amputation is reported to be a major but preventable public health problem that is associated with profound economic, social and psychological effects on the patient and family especially in developing countries where the prosthetic services are poor. The purpose of this study was to outline the patterns, indications and short term complications of major limb amputations and to compare our experience with that of other published data.
This was a descriptive cross-sectional study that was conducted at Bugando Medical Centre between March 2008 and February 2010. All patients who underwent major limb amputation were, after informed consent for the study, enrolled into the study. Data were collected using a pre-tested, coded questionnaire and analyzed using SPSS version 11.5 computer software.
A total of 162 patients were entered into the study. Their ages ranged between 2–78 years (mean 28.30 ± 13.72 days). Males outnumbered females by a ratio of 2:1. The majority of patients (76.5%) had primary or no formal education. One hundred and twelve (69.1%) patients were unemployed. The most common indication for major limb amputation was diabetic foot complications in 41.9%, followed by trauma in 38.4% and vascular disease in 8.6% respectively. Lower limbs were involved in 86.4% of cases and upper limbs in 13.6% of cases giving a lower limb to upper limb ratio of 6.4:1 Below knee amputation was the most common procedure performed in 46.3%. There was no bilateral limb amputation. The most common additional procedures performed were wound debridement, secondary suture and skin grafting in 42.3%, 34.5% and 23.2% respectively. Two-stage operation was required in 45.4% of patients. Revision amputation rate was 29.6%. Post-operative complication rate was 33.3% and surgical site infection was the most common complication accounting for 21.0%. The mean length of hospital stay was 22.4 days and mortality rate was 16.7%.
Complications of diabetic foot ulcers and trauma resulting from road traffic crashes were the most common indications for major limb amputation in our environment. The majority of these amputations are preventable by provision of health education, early presentation and appropriate management of the common indications.
PMCID: PMC3413574  PMID: 22578187
Major limb amputation; Amputation patterns; Short-term outcome; Tanzania
4.  Biomechanics of the Diabetic Foot: Consideration in Limb Salvage 
Advances in Wound Care  2013;2(3):107-111.
The biomechanics of the diabetic foot is altered and maladaptive. We lack a thorough understanding of the functional consequences of limb salvage. We currently rely on observation and descriptive data pertaining to the biomechanics of the diabetic foot.
Recent Advances
Technology has driven our ability to objectively describe biomechanics of the diabetic foot. Dynamic, segmental, gait analysis in conjunction with peak plantar pressure measurements have provided valuable insight.
Critical Issues
The biomechanical pathogenesis of a chronic ulceration that necessitates limb salvage is difficult to capture. The subsequent changes that occur after limb salvage are even more difficult to understand. However, methodical biomechanical analysis over the past several decades have provided a deeper understanding of diabetic foot function.
Future Directions
Ultimately, a better understanding of the biomechanics of the diabetic foot would allow us to better select the most appropriate amputation level and maximize function after limb salvage attempt.
PMCID: PMC3840549  PMID: 24527334
5.  A retrospective analysis of amputation rates in diabetic patients: can lower extremity amputations be further prevented? 
Lower extremity amputations are costly and debilitating complications in patients with diabetes mellitus (DM). Our aim was to investigate changes in the amputation rate in patients with DM at the Karolinska University Hospital in Solna (KS) following the introduction of consensus guidelines for treatment and prevention of diabetic foot complications, and to identify risk groups of lower extremity amputations that should be targeted for preventive treatment.
150 diabetic and 191 nondiabetic patients were amputated at KS between 2000 and 2006; of these 102 diabetic and 99 nondiabetic patients belonged to the catchment area of KS. 21 diabetic patients who belonged to KS catchment area were amputated at Danderyd University Hospital. All patients' case reports were searched for diagnoses of diabetes, vascular disorders, kidney disorders, and ulcer infections of the foot.
There was a 60% reduction in the rate of amputations performed above the ankle in patients with DM during the study period. Patients with DM who underwent amputations were more commonly affected by foot infections and kidney disorders compared to the nondiabetic control group. Women with DM were 10 years older than the men when amputated, whereas men with DM underwent more multiple amputations and had more foot infections compared to the women. 88% of all diabetes-related amputations were preceded by foot ulcers. Only 30% of the patients had been referred to the multidisciplinary foot team prior to the decision of amputation.
These findings indicate a reduced rate of major amputations in diabetic patients, which suggests an implementation of the consensus guidelines of foot care. We also propose further reduced amputation rates if patients with an increased risk of future amputation (i.e. male sex, kidney disease) are identified and offered preventive treatment early.
PMCID: PMC3362773  PMID: 22385577
Lower extremity amputations; Diabetic foot; Foot ulcer; Diabetic complications
6.  A Systematic Review of Outcomes and Complications of Reconstruction and Amputation for Type IIIB and IIIC Fractures of the Tibia 
Plastic and reconstructive surgery  2008;122(6):1796-1805.
The question of whether to recommend amputation or salvage after IIIB and IIIC tibial fractures remains unanswered. The purpose of this study is to conduct a systematic review to derive evidence-based recommendation concerning primary amputation versus limb salvage for IIIB and IIIC open tibial fractures.
Articles from Medline, Cinahl and Embase that met pre-determined criteria were included. Outcomes of interest included: hospital stay duration, complications, rehabilitation time, quality of life, limb function, pain, and return to work data. Pooling of statistical data was performed when possible.
We reviewed 1,947 articles, and 28 observational studies were included. Length of hospital stay was 56.9 days for salvage patients and 63.7 days for amputees. The most common complications after salvage attempt were osteomyelitis (17.9%), nonunion (15.5%), secondary amputation (7.3%) and flap failure (5.8%). Rehabilitation time for salvaged patients was reported as time to union (10.2 months) and time to full weight-bearing (8.1 months). Pain, quality of life and limb function outcomes were assessed differently among studies and could not be combined. Percent of patients who returned to work was 63.5% for salvage patients and 73% for amputees.
The current literature offers no evidence to support superior outcomes of either limb salvage or primary amputation for IIIB and IIIC tibial fractures. When outcomes are similar between two treatment strategies, economic analysis that incorporates cost and preference (utility) may define an optimal treatment strategy to guide physicians and patients.
PMCID: PMC4410276  PMID: 19050533
Systematic Review; Meta-analysis; Tibial Fractures; Amputation; Limb Salvage; Outcomes
7.  Salvage of Diffuse Ankle Osteomyelitis by Single-Stage Resection and Circumferential Frame Compression Arthrodesis 
Salvage of diffuse ankle osteomyelitis, especially in compromised hosts, is a challenging problem. The purpose of this report was to evaluate early complications and results using a standardized salvage protocol. Eight patients with diffuse ankle osteomyelitis were treated by resection of all infected tissue and hybrid-frame compression arthrodesis. At presentation, five had open wounds. According to the Cierny/Mader classification, all had diffuse anatomic involvement and six of eight were compromised hosts. Seven had central distal tibial column involvement and one had primarily talar involvement. Surgical technique involved a two-incision approach, removal of all infected material and application of a compression circumferential frame with five thin wires across the foot, two across the tibia and two half-pins in the tibia. Fusion of eight ankles and four subtalar joints was attempted. All patients received six weeks of intravenous antibiotics. Open wounds were treated with wound vacuum assisted closure (VACs) devices until closure was achieved. Frames were removed at three months and walking casts were applied for one to two more months. Ankle sepsis was eradicated in all patients. Seven of eight ankles fused at an average of 13.5 weeks (range, 10 to 16 weeks). One limb required below-knee amputation (BKA) at five weeks due to nonreconstructible vascular insufficiency. Three of four subtalar joints fused. Fixation problems included two pin-track infections cleared with oral cephalexin and one broken half-pin. Two diabetic Charcot patients required long-term ankle-foot orthosis (AFO) use due to subtalar instability. At average 3.4-year follow-up, none of the seven fused ankles has required further surgery. Use of this standardized salvage treatment protocol for these difficult problems in selected patients was effective with a relatively low associated complication rate.
PMCID: PMC1888789  PMID: 16089072
8.  Similar Survival but Better Function for Patients after Limb Salvage versus Amputation for Distal Tibia Osteosarcoma 
Amputation has been the standard surgical treatment for distal tibia osteosarcoma. Advances in surgery and chemotherapy have made limb salvage possible. However, it is unclear whether limb salvage offers any improvement in function without compromising survival.
We therefore compared the survival, local recurrence, function, and complications of patients with distal tibia osteosarcoma treated with limb salvage or amputation.
We retrospectively reviewed 42 patients with distal tibia osteosarcoma treated from 1985 to 2010. Nineteen patients had amputations and 23 had limb salvage and allograft reconstructions. We graded the histology using Broders classification, and staged patients using the Musculoskeletal Tumor Society (MSTS) and American Joint Committee on Cancer (AJCC) systems. The tumor grades tended to be higher in the group of patients who had amputations. We determined survival, local recurrence, MSTS function, and complications. The minimum followup was 8 months (median, 60 months; range, 8–288 months).
The survival of patients who had limb salvage was similar to that of patients who had amputations: 84% at 120 and 240 months versus 74%, respectively. The incidence of local recurrence was similar: three of 23 patients who had limb salvage versus no patients who had amputations. The mean MSTS functional score tended to be higher in patients who had limb salvage compared with those who had amputations: 76% (range, 30%–93%) versus 71% (range, 50%–87%), respectively. The incidence of complications was similar.
Patients treated with either limb salvage or amputation experience similar survival, local recurrence, and complications, but better function is achievable for patients treated with limb salvage versus amputation. Local recurrence and complications are more common in patients with limb salvage.
Level of Evidence
Level III, retrospective comparative study. See the Guidelines for Authors for a complete description of levels of evidence.
PMCID: PMC3348295  PMID: 22270466
9.  A developing world experience with distal foot amputations for diabetic limb salvage 
Diabetic Foot & Ankle  2013;4:10.3402/dfa.v4i0.22477.
To evaluate the functional outcome, morbidity, and viability of foot salvage in diabetic patients.
Materials and methods
This prospective case series was conducted from March 2007 to December 2012 at the department of surgery Pakistan Ordnance Factories Hospital, Wah Cantt, Pakistan. 123 males and 26 female patients were included in the study. All the patients were treated after getting admitted in the hospital and wounds were managed with daily dressings, nursing care and debridement of necrotic tissue with adequate antibiotic coverage.
In total, 149 patients (mean age: 56±7.52 years) with 171 amputations were included in the study. The mean duration of diabetes mellitus (DM) was 9±4.43 years. Ninety-seven percent of the patients were diagnosed with type 2 DM. Wound debridement was performed under general anesthesia in 48 (33.2%) patients, whereas local anesthesia was used for the rest of the patients after having good glycemic control and improvement in general health. The most common pathogen isolated from the infected wounds was Staphylococcus aureus in approximately 46% cases. Regarding the types of amputation, partial toe amputation was performed in 21 (12.2%) cases, second-toe amputation in 60 (35%) cases, hallux amputation in 41 (24%) cases, multiple toe amputations in 29 (17%) cases, bilateral feet involvement was observed in 16 (9.3%) cases, and transmetatarsal amputation was performed in 4 (2.3%) cases. The wounds healed well except in 19 cases where amputation had to be revised to a more proximal level. Thirty-nine patients died during the study period: 3 died of wound-related complications and 36 died of systemic complications.
With the ever-increasing epidemic of DM, the number of patients with diabetic foot ulcers has also significantly risen. Early surgical management with good glycemic control and foot care with close monitoring can decrease amputations and thus foot salvage can be successfully achieved.
PMCID: PMC3805841  PMID: 24155996
diabetic foot; limb salvage; glycemic control; amputations; infections
10.  Limb salvage surgery 
The threat of lower limb loss is seen commonly in severe crush injury, cancer ablation, diabetes, peripheral vascular disease and neuropathy. The primary goal of limb salvage is to restore and maintain stability and ambulation. Reconstructive strategies differ in each condition such as: Meticulous debridement and early coverage in trauma, replacing lost functional units in cancer ablation, improving vascularity in ischaemic leg and providing stable walking surface for trophic ulcer. The decision to salvage the critically injured limb is multifactorial and should be individualised along with laid down definitive indications. Early cover remains the standard of care, delayed wound coverage not necessarily affect the final outcome. Limb salvage is more cost-effective than amputations in a long run. Limb salvage is the choice of procedure over amputation in 95% of limb sarcoma without affecting the survival. Compound flaps with different tissue components, skeletal reconstruction; tendon transfer/reconstruction helps to restore function. Adjuvant radiation alters tissue characters and calls for modification in reconstructive plan. Neuropathic ulcers are wide and deep often complicated by osteomyelitis. Free flap reconstruction aids in faster healing and provides superior surface for offloading. Diabetic wounds are primarily due to neuropathy and leads to six-fold increase in ulcerations. Control of infections, aggressive debridement and vascular cover are the mainstay of management. Endovascular procedures are gaining importance and have reduced extent of surgery and increased amputation free survival period. Though the standard approach remains utilising best option in the reconstruction ladder, the recent trend shows running down the ladder of reconstruction with newer reliable local flaps and negative wound pressure therapy.
PMCID: PMC3901908  PMID: 24501463
Limb salvage; limb trauma; lower limb reconstruction; foot ulcers
11.  Reliability of the mangled extremity severity score in combat-related upper and lower extremity injuries 
Indian Journal of Orthopaedics  2015;49(6):656-660.
Decision of limb salvage or amputation is generally aided with several trauma scoring systems such as the mangled extremity severity score (MESS). However, the reliability of the injury scores in the settling of open fractures due to explosives and missiles is challenging. Mortality and morbidity of the extremity trauma due to firearms are generally associated with time delay in revascularization, injury mechanism, anatomy of the injured site, associated injuries, age and the environmental circumstance. The purpose of the retrospective study was to evaluate the extent of extremity injuries due to ballistic missiles and to detect the reliability of mangled extremity severity score (MESS) in both upper and lower extremities.
Materials and Methods:
Between 2004 and 2014, 139 Gustillo Anderson Type III open fractures of both the upper and lower extremities were enrolled in the study. Data for patient age, fire arm type, transporting time from the field to the hospital (and the method), injury severity scores, MESS scores, fracture types, amputation levels, bone fixation methods and postoperative infections and complications retrieved from the two level-2 trauma center's data base. Sensitivity, specificity, positive and negative predictive values of the MESS were calculated to detect the ability in deciding amputation in the mangled limb.
Amputation was performed in 39 extremities and limb salvage attempted in 100 extremities. The mean followup time was 14.6 months (range 6–32 months). In the amputated group, the mean MESS scores for upper and lower extremity were 8.8 (range 6–11) and 9.24 (range 6–11), respectively. In the limb salvage group, the mean MESS scores for upper and lower extremities were 5.29 (range 4–7) and 5.19 (range 3–8), respectively. Sensitivity of MESS in upper and lower extremities were calculated as 80% and 79.4% and positive predictive values detected as 55.55% and 83.3%, respectively. Specificity of MESS score for upper and lower extremities was 84% and 86.6%; negative predictive values were calculated as 95.45% and 90.2%, respectively.
MESS is not predictive in combat related extremity injuries especially if between a score of 6–8. Limb ischemia and presence or absence of shock can be used in initial decision-making for amputation.
PMCID: PMC4705733  PMID: 26806974
Amputation; combat injuries; lower extremity; mangled extremity severity score; upper extremity; Open fractures; amputation; lower extremity; upper extremity
12.  Vascular Surgery, Microsurgery and Supramicrosurgery for Treatment of Chronic Diabetic Foot Ulcers to Prevent Amputations 
PLoS ONE  2013;8(9):e74704.
Diabetic foot ulcers occur in approximately 2,5% of patients suffering from diabetes and may lead to major infections and amputation. Such ulcers are responsible for a prolonged period of hospitalization and co- morbidities caused by infected diabetic foot ulcers. Small, superficial ulcers can be treated by special conservative means. However, exposed bones or tendons require surgical intervention in order to prevent osteomyelitis. In many cases reconstructive surgery is necessary, sometimes in combination with revascularization of the foot.
There are studies on non surgical treatment of the diabetic foot ulcer. Most of them include patients, classified Wagner 1-2 without infection. Patients presenting Wagner 3D and 4D however are at a higher risk of amputation. The evolution of microsurgery has extended the possibilities of limb salvage. Perforator based flaps can minimize the donorsite morbidity.
Patients and Methods
41 patients were treated with free tissue transfer for diabetic foot syndrome and chronic defects. 44 microvascular flaps were needed. The average age of patients was 64.3 years. 18 patients needed revascularization. 3 patients needed 2 microvascular flaps. In 6 cases supramicrosurgical technique was used.
There were 2 flap losses leading to amputation. 4 other patients required amputation within 6 months postoperatively due to severe infection or bypass failure. Another 4 patients died within one year after reconstruction. The remaining patients were ambulated.
Large defects of the foot can be treated by free microvascular myocutaneous or fasciocutaneous tissue transfer. If however, small defects, exposing bones or tendons, are not eligible for local flaps, small free microvascular flaps can be applied. These flaps cause a very low donor site morbidity. Arterialized venous flaps are another option for defect closure.
Amputation means reduction of quality of life and can lead to an increased mortality postoperatively.
PMCID: PMC3772888  PMID: 24058622
13.  Major limb amputations: an audit of indications in a suburban surgical practice. 
BACKGROUND: Advancements in vascular and microsurgery in developed countries have led to fewer major limb amputations. AIM: This audit of major limb amputations performed at the Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria, between June 1998 and May 2003, was conducted to find out the indications for amputation and highlight those cases that could be salvageable. PATIENTS AND METHODS: This was a retrospective study. Case notes of all patients who had major limb amputations were examined for patients' age, sex, time of presentation, limb affected, indications for amputation, the severity of crush injury to limb, stage of musculoskeletal tumors and Wagner's grade of diabetic foot. RESULTS: A total of 71 limbs were amputated in 69 patients; 56 limbs (78.1%) were unsalvageable, while 15 limbs (21.1%) were salvageable. Trauma accounted for 76% followed by 22% performed due to gangrene secondary to diabetes mellitus. Out of the 56 unsalvageable limbs, 31 patients presented with severely crushed limbs. Out of the 15 salvageable limbs, there were 11 cases of clean-cut traumatic amputations, two of soft-tissue sarcoma and one each of ruptured popliteal aneurysm and stenosed popliteal artery. CONCLUSION: Trauma and diabetes mellitus were leading indications for amputation. Expertise in limb salvage procedures and availability of appropriate equipment may reduce the numbers of amputations performed.
PMCID: PMC2568563  PMID: 15719875
14.  Predictive factors for successful limb salvage surgery in diabetic foot patients 
BMC Surgery  2014;14:113.
The goal of salvage surgery in the diabetic foot is maximal preservation of the limb, but it is also important to resect unviable tissue sufficiently to avoid reamputation. This study aims to provide information on determining the optimal amputation level that allows preservation of as much limb length as possible without the risk of further reamputation by analyzing several predictive factors.
Between April 2004 and July 2013, 154 patients underwent limb salvage surgery for distal diabetic foot gangrene. According to the final level of amputation, the patients were divided into two groups: Patients with primary success of the limb salvage, and patients that failed to heal after the primary limb salvage surgery. The factors predictive of success, including comorbidity, laboratory findings, and radiologic findings were evaluated by a retrospective chart review.
The mean age of the study population was 63.9 years, with a male-to-female ratio of approximately 2:1. The mean follow-up duration was 30 months. Statistical analysis showed that underlying renal disease, limited activity before surgery, a low hemoglobin level, a high white blood cell count, a high C-reactive protein level, and damage to two or more vessels on preoperative computed tomography (CT) angiogram were significantly associated with the success or failure of limb salvage. The five-year survival rate was 81.6% for the limb salvage success group and 36.4% for the limb salvage failure group.
This study evaluated the factors predictive of the success of limb salvage surgery and identified indicators for preserving as much as possible of the leg of a patient with diabetic foot. This should help surgeons to establish the appropriate amputation level for a case of diabetic foot and help prevent consecutive operations.
PMCID: PMC4320552  PMID: 25551288
Diabetic foot; Major limb amputation; Limb salvage
15.  Severity of Diabetic Foot Infection and Rate of Limb Salvage 
Foot infections are limb threatening complications in patients with diabetes mellitus (DM) and proper classification of diabetic foot infection (DFI) severity is important in establishing the proper antibiotic regimen, the need for hospitalization and surgery and the risk of amputation. Our hypothesis was that patients with severe DFI would have a longer hospitalization than those with moderate DFI. The purposed of this study was two fold. The first purpose was to define DFI using readily available clinical information and objective parameters outlined by consensus statements. The second purpose of this study was the assess the amputation and limb salvage rates for hospitalized patients with DFI.
Materials and methods
The database of a single academic foot and ankle program was reviewed for patients who were hospitalized for a DFI from 2006-2011. Inpatient and outpatient electronic medical records identified 100 patients. Severe DFI was defined as having two or more objective findings of systemic toxicity and/or metabolic instability at the time of initial assessment.
The length of stay was significantly shorter for patients with a moderate infection than those with a severe infection (median 5 days versus 8 days, p=0.021). A non-significant trend indicating higher rates of limb salvage in patients with moderate infections compared to patients with severe infections was observed (94% versus 80%, p=0.081).
Summary and Conclusion
As hypothesized, patients with severe DFI had a median hospital stay that was 60% longer than patients with moderate DFI. In this sample, 55% of patients with a severe DFI required some type of amputation compared to 42 % of patients with a moderate DFI.
PMCID: PMC4016951  PMID: 23520292
diabetic foot infection definition severe
16.  Incidence of re-amputation following partial first ray amputation associated with diabetes mellitus and peripheral sensory neuropathy: a systematic review. 
Diabetic Foot & Ankle  2012;3:10.3402/dfa.v3i0.12169.
Diabetes mellitus with peripheral sensory neuropathy frequently results in forefoot ulceration. Ulceration at the first ray level tends to be recalcitrant to local wound care modalities and off-loading techniques. If healing does occur, ulcer recurrence is common. When infection develops, partial first ray amputation in an effort to preserve maximum foot length is often performed. However, the survivorship of partial first ray amputations in this patient population and associated re-amputation rate remain unknown. Therefore, in an effort to determine the actual re-amputation rate following any form of partial first ray amputation in patients with diabetes mellitus and peripheral neuropathy, the authors conducted a systematic review. Only studies involving any form of partial first ray amputation associated with diabetes mellitus and peripheral sensory neuropathy but without critical limb ischemia were included. Our search yielded a total of 24 references with 5 (20.8%) meeting our inclusion criteria involving 435 partial first ray amputations. The weighted mean age of patients was 59 years and the weighted mean follow-up was 26 months. The initial amputation level included the proximal phalanx base 167 (38.4%) times; first metatarsal head resection 96 (22.1%) times; first metatarsal-phalangeal joint disarticulation 53 (12.2%) times; first metatarsal mid-shaft 39 (9%) times; hallux fillet flap 32 (7.4%) times; first metatarsal base 29 (6.7%) times; and partial hallux 19 (4.4%) times. The incidence of re-amputation was 19.8% (86/435). The end stage, most proximal level, following re-amputation was an additional digit 32 (37.2%) times; transmetatarsal 28 (32.6%) times; below-knee 25 (29.1%) times; and LisFranc 1 (1.2%) time. The results of our systematic review reveal that one out of every five patients undergoing any version of a partial first ray amputation will eventually require more proximal re-amputation. These results reveal that partial first ray amputation for patients with diabetes and peripheral sensory neuropathy may not represent a durable, functional, or predictable foot-sparing amputation and that a more proximal amputation, such as a balanced transmetatarsal amputation, as the index amputation may be more beneficial to the patient. However, this remains a matter for conjecture due to the limited data available and, therefore, additional prospective investigations are warranted.
PMCID: PMC3284264  PMID: 22396832
diabetic foot; hallux; ulceration; osteomyelitis; metatarsal; resection
17.  Diabetic foot infections with osteomyelitis: efficacy of combined surgical and medical treatment 
Diabetic Foot & Ankle  2012;3:10.3402/dfa.v3i0.18809.
Diabetic foot infections are a high risk for lower extremity amputation in patients with dense peripheral neuropathy and/or peripheral vascular disease. When they present with concomitant osteomyelitis, it poses a great challenge to the surgical and medical teams with continuing debates regarding the treatment strategy. A cohort prospective study conducted between October 2005 and October 2010 included 330 diabetic patients with osteomyelitis mainly involving the forefoot (study group) and 1,808 patients without foot osteomyelitis (control group). Diagnosis of osteomyelitis was based on probing to bone test with bone cultures for microbiological studies and/or repeated plain radiographic findings. Surgical treatment included debridement, sequestrectomy, resections of metatarsal and digital bones, or toe amputation. Antibiotics were started as empirical and modified according to the final culture and sensitivities for all patients. Patients were followed for at least 1 year after wound healing. The mean age of the study group was 56.7 years (SD = 11.4) compared to the control group of 56.3 years (SD = 12.1), while the male to female ratio was 3:1. At initial presentation, 82.1% (n=271) of the study group had an ulcer penetrating the bone or joint level. The most common pathogens were Staphylococcus aureus (33.3%), Pseudomonas aeruginosa (32.2%), and Escherichia coli (22.2%) with an almost similar pattern in the control group. In the study group, wound healing occurred in less than 6 months in 73% of patients compared to 89.9% in the control group. In the study group, 52 patients (15.8%) had a major lower extremity amputation versus 61 in the control group (3.4%) (P=0.001). During the postoperative follow-up visits, 12.1% of patients in each group developed wound recurrence. In conclusion, combined surgical and medical treatment for diabetic foot osteomyelitis can achieve acceptable limb salvage rate and also reduce the duration of time to healing along with the duration of antibiotic treatment and wound recurrence rate.
PMCID: PMC3464066  PMID: 23050065
diabetic foot; osteomyelitis; ulcer; amputation; neuropathy
18.  Chronic neuropathic ulcer is not the most common antecedent of lower limb infection or amputation among diabetics admitted to a regional hospital in Jamaica: results from a prospective cohort study 
BMC Surgery  2015;15:104.
Guidelines of the International Consensus on the Diabetic Foot state that “Amputation of the lower extremity or part of it is usually preceded by a foot ulcer”. The authors’ impression has been that this statement might not be applicable among patients treated in our institution. A prospective cohort study was designed to determine the frequency distribution of antecedents of lower limb infection or gangrene and amputation among adult diabetics admitted to a Regional Hospital in western Jamaica.
Adult diabetics admitted to Hospital with a primary diagnosis of lower limb infection and/or gangrene were eligible for recruitment for a target sample size of 126. Thirty five variables were assessed for each patient-episode of infection and/or gangrene, main outcome variable being amputation during admission or 6-months follow-up. Primary statistical output is the frequency distribution of antecedents/precipitants of lower limb infection and/or gangrene. The data is interrogated by univariate and multivariable logistic regression for variables statistically associated with the main antecedent/precipitant events.
Data for 128 patient-episodes were recorded. Most common antecedents/precipitants, in order of decreasing frequency, were idiopathic acute soft tissue infection/ulceration (30.5 %, CI; 22.6–39.2 %), chronic neuropathic ulcer (23.4 %, CI; 16.4–31.7 %), closed puncture wounds (19.5 %, CI; 13.1–27.5 %) and critical limb ischemia (7.8 %, CI; 3.8–13.9 %). Variables positively associated with non-traumatic antecedents/precipitants at the 5 % level of significance were male gender and non-ulcerative foot deformity for idiopathic acute soft tissue infection/ulcer; diabetes >5 years, previous infection either limb, insulin dependence and peripheral sensory neuropathy for chronic neuropathic ulcer and older age, diabetes >5 years, hypertension, non-palpable distal pulses and ankle-brachial index ≤0.4 for critical limb ischemia.
Chronic neuropathic ulcer accounted for only 23.4 % of lower limb infections and 27.7 % of amputations in this population of diabetics, making it the second most common antecedent of either after acute idiopathic soft tissue infection/ulcer at 30.5 and 34.7 % respectively. Trauma as a group (defined as closed puncture wounds, lacerations, contusion/blunt trauma and burns) also accounted for a greater number of lower limb infections but fewer amputations than chronic neuropathic ulcer, at 32 and 19.5 % respectively.
PMCID: PMC4578687  PMID: 26391233
Soft tissue infection diabetes; Abscess diabetes; Diabetic foot ulcer; Trauma diabetes; Puncture wounds foot; Critical limb ischemia diabetes; Diabetes Caribbean; Diabetes developing countries
19.  Lower limb biomechanical characteristics of patients with neuropathic diabetic foot ulcers: the diabetes foot ulcer study protocol 
Foot ulceration is the main precursor to lower limb amputation in patients with type 2 diabetes worldwide. Biomechanical factors have been implicated in the development of foot ulceration; however the association of these factors to ulcer healing remains less clear. It may be hypothesised that abnormalities in temporal spatial parameters (stride to stride measurements), kinematics (joint movements), kinetics (forces on the lower limb) and plantar pressures (pressure placed on the foot during walking) contribute to foot ulcer healing. The primary aim of this study is to establish the biomechanical characteristics (temporal spatial parameters, kinematics, kinetics and plantar pressures) of patients with plantar neuropathic foot ulcers compared to controls without a history of foot ulcers. The secondary aim is to assess the same biomechanical characteristics in patients with foot ulcers and controls over-time to assess whether these characteristics remain the same or change throughout ulcer healing.
The design is a case–control study nested in a six-month longitudinal study. Cases will be participants with active plantar neuropathic foot ulcers (DFU group). Controls will consist of patients with type 2 diabetes (DMC group) and healthy participants (HC group) with no history of foot ulceration. Standardised gait and plantar pressure protocols will be used to collect biomechanical data at baseline, three and six months. Descriptive variables and primary and secondary outcome variables will be compared between the three groups at baseline and follow-up.
It is anticipated that the findings from this longitudinal study will provide important information regarding the biomechanical characteristic of type 2 diabetes patients with neuropathic foot ulcers. We hypothesise that people with foot ulcers will demonstrate a significantly compromised gait pattern (reduced temporal spatial parameters, kinematics and kinetics) at base line and then throughout the follow-up period compared to controls. The study may provide evidence for the design of gait-retraining, neuro-muscular conditioning and other approaches to off-load the limbs of those with foot ulcers in order to reduce the mechanical loading on the foot during gait and promote ulcer healing.
Electronic supplementary material
The online version of this article (doi:10.1186/s12902-015-0057-7) contains supplementary material, which is available to authorized users.
PMCID: PMC4619003  PMID: 26499881
Diabetic neuropathies; Diabetic foot; Foot ulcer; Longitudinal studies; Gait; Protocols; Plantar pressure
20.  Free Tissue Transfer for Limb Salvage in High-Risk Patients: Worth the Risk 
Advances in Wound Care  2013;2(2):63-68.
Mircosurgical free tissue transfer is a powerful tool in the arsenal of reconstructive surgeons, oftentimes as the final option in limb salvage before amputation. Patients presenting for limb salvage frequently carry with them multiple co-morbidities such as diabetes mellitus, end-stage renal disease, and peripheral vascular disease. Surgeons are oftentimes hesitant to attempt free tissue tranfer in these medically complex individuals due to beliefs that the patient would not tolerate prolonged anesthesia, the surgery is doomed to fail, or the patient would be better off with an amputation. Because amputees actually demonstrate higher mortality rates, the decision to not to proceed with limb salvage should be made with great care.
Recent Advances
By reviewing the success rates with free tissue transfer for limb salvage in high-risk patients, the target articles have shown that this option is indeed viable even in this patient population. Specifically, reasonable success rates are presented for limb salvage using free tissue transfer in patients with end-stage renal disease, a single-vessel leg and critical limb ischemia.
Critical Issues
The articles reviewed demonstrate that free tissue transfer for limb salvage in properly selected patients with end-stage renal disease or severe peripheral vascular disease is worth attempting. Before surgery, these patients must undergo a complete cardiac work-up regardless of previous cardiac history.
Future Directions
When necessary, free tissue transfer should be pursued by the reconstructive surgeon even in high-risk medically complex patients.
PMCID: PMC3840480  PMID: 24527327
21.  Amputation in Diabetic Patients 
Foot ulcers and their complications are an important cause of morbidity and mortality in diabetes. The present study examines the amputation risk criterion and the long term outcome in terms of amputations and mortality in patients with diabetic foot.
27 patients with diabetic foot lesions were studied. There were 15 patients with early lesions and 10 with advanced lesions. 15 patients were managed conservatively including local amputations and 12 with lower extremity amputations. 80% patients were males in 45-59 years of age group and all patients had more than 6 years of poorly controlled diabetes.
Precipitating factors included walking barefoot, history of minor trauma, infection, callosities or burns in 86% of patients. Major lower limb amputations were common in irregularly treated, poorly controlled diabetics due to infection in a limb devitalized by angiopathy and desensitised by neuropathy.
Diabetic foot ulcers are associated with high morbidity and mortality. Mortality was higher in ischaemic ulcers than neuropathic ulcers.
PMCID: PMC4923303  PMID: 27407841
Amputations; Diabetic foot; Aggressiveness
22.  Hyperbaric Oxygen Therapy for Non-Healing Ulcers in Diabetes Mellitus 
Executive Summary
To examine the effectiveness and cost-effectiveness of hyperbaric oxygen therapy (HBOT) to treat people with diabetes mellitus (DM) and non-healing ulcers. This policy appraisal systematically reviews the published literature in the above patient population, and applies the results and conclusions of the review to current health care practices in Ontario, Canada.
Although HBOT is an insured service in Ontario, the costs for the technical provision of this technology are not covered publicly outside the hospital setting. Moreover, access to this treatment is limited, because many hospitals do not offer it, or are not expanding capacity to meet the demand.
Clinical Need
Diabetes mellitus is a chronic disease characterized by an increase in blood sugar that can lead to many severe conditions such as vision, cardiac, and vascular disorders. The prevalence of DM is difficult to estimate, because some people who have the condition are undiagnosed or may not be captured through data that reflect access to the health care system. The Canadian Diabetic Association estimates there are about 2 million people in Canada with diabetes (almost 7% of the population). According to recent data, the prevalence of DM increased from 4.72% of the population aged 20 years and over in 1995, to 6.19% of the population aged 20 years and over in 1999, or about 680,900 people in 1999. Prevalence estimates expanded to 700,000 in 2003.
About 10% to 15% of people with DM develop a foot wound in their lifetimes because of underlying peripheral neuropathy and peripheral vascular disease. This equals between 70,000 and 105,000 people in Ontario, based on the DM prevalence estimate of 700,000 people. Without early treatment, a foot ulcer may fester until it becomes infected and chronic. Chronic wounds are difficult to heal, despite medical and nursing care, and may lead to impaired quality of life and functioning, amputation, or even death.
The Technology
Hyperbaric oxygen therapy has been in use for about 40 years. It is thought to aid wound healing by supplying oxygen to the wound. According to the Hyperbaric Oxygen Therapy Association, HBOT acts as a bactericidal, stops toxin production, and promotes tissue growth to heal difficult wounds.
During the procedure, a patient is placed in a compression chamber with increased pressure between 2.0 and 2.5 atmospheres absolute for 60 to 120 minutes, once or twice daily. In the chamber, the patient inhales 100% oxygen. Treatment usually runs for 15 to 20 sessions.
Noted complications are rare but may include claustrophobia; ear, sinus, or lung damage due to pressure; temporary worsening of short sightedness; and oxygen poisoning. Careful monitoring during the treatment sessions and follow-up by a trained health care provider is recommended.
Review Strategy
The aims of this health technology policy appraisal were to assess the effectiveness, safety, and cost-effectiveness of HBOT, either alone, or as an adjunct, compared with the standard treatments for non-healing foot or leg ulcers in patients with DM. The following questions were asked:
Alone or as an adjunct therapy, is HBOT more effective than other therapies for non-healing foot or leg ulcers in patients with DM?
If HBOT is effective, what is the incremental benefit over and above currently used strategies?
When is the best time in a wound treatment strategy to use HBOT?
What is the best treatment algorithm with HBOT?
The Medical Advisory Secretariat searched for health technology assessments in the published and grey literature. The search yielded 4 reports, which were published from 2000 to 2005. The most recent from the Cochrane Collaboration had a literature review and analysis of randomized control trials to 2003.
As an update to this review, as per the standard Medical Advisory Secretariat systematic review strategy, the abstracts of peer-reviewed publications were identified using Ovid MEDLINE, EMBASE, MEDLINE in-process and not-yet-indexed citations, Cochrane Database of Systematic Reviews, Cochrane CENTRAL, and INAHTA using key words and searching from January 1, 2003 to 2004.
The criteria for inclusion were as follows:
Patients with diabetes
Live human study
English-language study
HBOT as adjunctive therapy or alone
Randomized control trial
The number of excluded studies included the following:
2 animal studies
13 focus on condition other than DM
8 review/protocol for HBOT use
3 HBOT not focus of report
2 health technology assessments (2)
1 non-RCT
Outcomes of interest were wound healing and prevention of amputation.
The search yielded 29 articles published between 2003 and 2004. All 29 of these were excluded, as shown beside the exclusion criteria above. Therefore, this health technology policy assessment focused exclusively on the most recently published health technology assessments and systematic reviews.
Summary of Findings
Four health technology assessments and reviews were found. Cochrane Collaboration researchers published the most recent review in 2005. They included only randomized controlled trials and conducted a meta-analysis to examine wound healing and amputation outcomes. They found that, based on findings from 118 patients in 3 studies, HBOT may help to prevent major amputation (relative risk, 0.31; 95% confidence interval [CI], 0.13–0.71) with a number needed to treat (NNT) of 4 (95% CI, 3–11). They noted, however, that the point estimates derived from trials were not well reported, and had varying populations with respect to wound severity, HBOT regimens, and outcome measures. These noted limitations rendered the comparison of results from the trials difficult. Further, they suggested that the evidence was not strong enough to suggest a benefit for wound healing in general or for prevention of minor amputations.
The Medical Advisory Secretariat also evaluated the studies that the Cochrane Collaboration used in their analysis, and agreed with their evaluation that the quality of the evidence was low for major and minor amputations, but low to moderate for wound healing, suggesting that the results from new and well-conducted studies would likely change the estimates calculated by Cochrane and others.
In 2003, the Ontario Health Technology Advisory Committee recommended a more coordinated strategy for wound care in Ontario to the Ministry of Health and Long-term Care. This strategy has begun at the community care and long-term care institution levels, but is pending in other areas of the health care system.
There are about 700,000 people in Ontario with diabetes; of these, 10% to 15% may have a foot ulcer sometime in their lifetimes. Foot ulcers are treatable, however, when they are identified, diagnosed and treated early according to best practice guidelines. Routine follow-up for people with diabetes who may be at risk for neuropathy and/or peripheral vascular disease may prevent subsequent foot ulcers. There are 4 chambers that provide HBOT in Ontario. Fewer than 20 people with DM received HBOT in 2003.
The quality of the evidence assessing the effectiveness of HBOT as an adjunct to standard therapy for people with non-healing diabetic foot ulcers is low, and the results are inconsistent. The results of a recent meta-analysis that found benefit of HBOT to prevent amputation are therefore uncertain. Future well-conducted studies may change the currently published estimates of effectiveness for wound healing and prevention of amputation using HBOT in the treatment of non-healing diabetic foot ulcers.
Although HBOT is an insured service in Ontario, a well conducted, randomized controlled trial that has wound healing and amputation as the primary end-points is needed before this technology is used widely among patients with foot wounds due to diabetes.
PMCID: PMC3382405  PMID: 23074462
23.  Collective Therapy and Therapeutic Strategy for Critical Limb Ischemia 
Annals of Vascular Diseases  2013;6(1):27-32.
Objective: To determine a treatment strategy based on the outcomes of various previous interventions for critical limb ischemia in arteriosclerosis obliterans (ASO).
Material and Methods: We examined outcomes of 292 ASO patients who had had critical limb ischemia between May 1995 and July 2009. Patients underwent the following procedures in 167 cases: aortofemoral bypass (n = 14), femorofemoral crossover bypass (n = 29), femoropopliteal bypass (n = 104) and femorotibial bypass (n = 40). Other procedures included bypass only (n = 147), bypass combined with thromboendarterectomy (n = 10), bypass combined with endovascular therapy (n = 6), bypass combined with lumbar sympathectomy (n = 2), endovascular therapy combined with thromboendarterectomy (n = 4), endovascular therapy (n = 19), lumbar sympathectomy (n = 6), conservative therapy (n = 65), and major amputation (n = 31). We also calculated P3 risk scores and measured transcutaneous oxygen pressure (tcPO2) and skin perfusion pressure (SPP) before and after therapy.
Results: The limb salvage rate was 87% at 2 years in the arterial reconstruction group. In the low-risk group (a P 3 risk score of 3), the 1-year amputation-free survival rate was 96%. In the medium-risk group (a P 3 risk score of 4–7), the 1-year amputation-free survival rate was 88%. In the high-risk group (a P 3 risk score of 8), the 1-year amputation-free survival rate was 66%. The hospital death rate in the arterial reconstruction group was 3.2%, all of whom were patients who underwent bypass. The survival rate at 5 years was 65% and 36% in the conservative therapy only group. Ulcers healed in 140 out of 144 patients. The 4 patients with unhealed infections had tcPO2 or SPP values of more than 30 mmHg after treatment. Major amputations were performed in 4 of 5 patients who had tcPO2 or SPP values from 20 to 30 mmHg after treatment. Major amputations were performed in all 6 patients who had tcPO2 or SPP values of less than 20 mmHg after treatment.
Conclusion: In cases with tcPO2 or SPP values of more than 30 mmHg, an ulcer will probably heal, except in infected cases. We suggest that, if these values are less than 30 mmHg, complete revascularization should be performed. The P3 risk score was useful in predicting limb salvage in the current series. Hybrid therapy in bypass and endovascular therapy must be performed in cases where patients are in a generally poor condition. It is important to attempt amelioration in limb salvage and to control the operative mortality rate with sufficient perioperative control. (English Translation of Jpn J Vasc Surg 2011;20:905–911)
PMCID: PMC3634996  PMID: 23641280
critical limb ischemia; hybrid therapy; transcutaneous oxygen pressure; skin perfusion pressure
24.  Strategy of Surgical Management of Peripheral Neuropathy Form of Diabetic Foot Syndrome in Ghana 
Plastic Surgery International  2014;2014:185023.
Introduction. Foot disorders such as ulceration, infection, and gangrene which are often due to diabetes mellitus are some major causes of morbidity and high amputation. Aim. This study aims to use a group of methods for the management of diabetic foot ulcers (DFU) in order to salvage the lower limb so as to reduce the rate of high amputations of the lower extremity. Materials and Methods. A group of different advanced methods for the management of DFU such as sharp debridement of ulcers, application of vacuum therapy, and other forms of reconstructive plastic surgical procedures were used. Data collection was done at 3 different hospitals where the treatments were given. Results. Fifty-four patients with type 2 diabetes mellitus were enrolled in the current study: females n = 37 (68.51%) and males n = 17 (31.49%) with different stages of PEDIS classification. They underwent different methods of surgical management: debridement, vacuum therapy (some constructed from locally used materials), and skin grafting giving good and fast results. Only 4 had below knee amputations. Conclusion. Using advanced surgical wound management including reconstructive plastic surgical procedures, it was possible to reduce the rate of high amputations of the lower limb.
PMCID: PMC4131423  PMID: 25152815
25.  Randomized Prospective Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor as Adjunctive Therapy for Limb-Threatening Diabetic Foot Infection 
Adult diabetic patients admitted to our Diabetes Center from September 1996 to January 1998 for severe, limb-threatening foot infection were consecutively enrolled in a prospective, randomized, controlled clinical study aimed at assessing the safety and efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) (lenograstim) as an adjunctive therapy for the standard treatment of diabetic foot infection. Forty patients, all of whom displayed evidence of osteomyelitis and long-standing ulcer infection, were randomized 1:1 to receive either conventional treatment (i.e., antimicrobial therapy plus local treatment) or conventional therapy plus 263 μg of G-CSF subcutaneously daily for 21 days. The empiric antibiotic treatment (a combination of ciprofloxacin plus clindamycin) was further adjusted, when necessary, according to the results of cultures and sensitivity testing. Microbiologic assessment of foot ulcers was performed by both deep-tissue biopsy and swab cultures, performed at enrollment and on days 7 and 21 thereafter. Patients were monitored for 6 months; the major endpoints (i.e., cure, improvement, failure, and amputation) were blindly assessed at weeks 3 and 9. At enrollment, both patient groups were comparable in terms of both demographic and clinical data. None of the G-CSF-treated patients experienced either local or systemic adverse effects. At the 3- and 9-week assessments, no significant differences between the two groups could be observed concerning the number of patients either cured or improved, the number of patients displaying therapeutic failure, or the species and number of microorganisms previously yielded from cultures at day 7 and day 21. Conversely, among this small series of patients the cumulative number of amputations observed after 9 weeks of treatment appeared to be lower in the G-CSF arm; in fact, only three patients (15%) in this group had required amputation, whereas nine patients (45%) in the other group had required amputation (P = 0.038). In conclusion, the administration of G-CSF for 3 weeks as an adjunctive therapy for limb-threatening diabetic foot infection was associated with a lower rate of amputation within 9 weeks after the commencement of standard treatment. Further clinical studies aimed at precisely defining the role of this approach to this serious complication of diabetes mellitus appear to be justified.
PMCID: PMC90429  PMID: 11257020

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