This study was a uni-centre, open label, phase III, comparative study. Consecutive type 2 diabetes patients who presented with an ulcer up to Wagner's grade III classification12
(Grade I, superficial ulcer; grade II deep ulcer probing to tendon, capsule or bone; grade III deep ulcer with abscess, osteomyelitis or joint sepsis;) were enrolled in this study at Diabetes Research Centre, Chennai, between August 2008 and February 2009. Subjects who had clinical signs of severe infection, wound that had exposed bone and unwillingness to participate in the study were excluded. The study protocol was approved by the ethics committee of the institution. The patients were fully informed regarding the composition of the cream and its role in treating infection. All the study participants gave written informed consent.
Active ingredients of diabetic wound care cream: (Polyherbal formulation):
Glycyrrhiza glabra 0.20 per cent (Yastimadhu Athimathuram) - It improves normal cell multiplication in a wound and in combination with ketaki and Shorea robusta (kumkilium) it forms a fine protective layer over the wound, accelerating the growth of normal tissue, which gets absorbed into the tissue later.
Musa paradisiaca 19.42 per cent (Kadali vazhaikilangu Kadali) - It tightens the open wound, reduces the wound area and accelerates wound healing. It also reduces the kelloid growth and accelerates the normal tissue growth.
Curcuma longa 2.43 per cent (Manjal turmeric) - It possess anti-inflammatory activity, antiseptic and helps in wound healing. It effectively controls normalcy of tissue glucose level in the wound area. It helps in the natural repair of micro vascular structure.
Pandanus odaratissimus 9.70 per cent (Thazhai / Chevuda Ketaki) - This contains natural fibres with microcrystalline calcium embedded in it which forms foundation layer for the tissue growth like natural fibrogen network over which normal dermal layer can grow.
Aloe vera 4.85 per cent (Sothukathazhai) - It increases the cytogenesis, cleanses the wound and controls the tissue glucose level. Various constituents of aloe vera have been shown to have anti-inflammatory activity as well as it stimulates the wound healing.
Cocos nucifera oil (Kera thailam, coconut milk) - It supplies nutrition and polysaccharides and enhances the growth of the tissue.
A total of 40 (M: F=26:14) patients with type 2 diabetes were randomly assigned into two groups: group 1 (n=20) was treated with diabetic wound cream (a polyherbal formulation prepared by Cholayil Product and Services, Chennai, India); group 2 (n=20) was treated with silversulphadiazine cream. The enrollment of the subjects was done after the debridement of the ulcer. The polyherbal formulation cream had various constituents having antimicrobial, anti-inflammatory properties. Cream was employed in the treatment owing to its assured safety and efficacy.
Age and duration of diabetes was recorded for all patients. HbA1c % was estimated by immunoturbidimetric method13
. The diagnosis of lower-extremity vascular insufficiency was made clinically on the basis of absence of both pedal pulses of the involved foot and/or an ankle-brachial pressure index of <0.914
. Neuropathy was diagnosed by vibration perception threshold (VPT)15
and a value of >25 V was considered as abnormal. The anatomic location of the wound, tissues and vascular status was recorded for all the patients. All the patients were followed for a period of 5 months.
The baseline ulcer size was between 2-50 cm2. The ulcer tracing was done for each patient in a sterile acetate sheet. The photographs of the wound was taken at the baseline i.e., before the application of the cream and at each follow up visit. The ulcers greatest length and width was measured at baseline and follow up. Patients were initially seen in the diabetic foot clinic on a weekly basis and were provided with the best possible care for their ulcers at each visit. Broad spectrum antibiotics were prescribed if ulcers showed clinical signs of infection. The dressings were changed daily after a wash with normal saline followed by the local application of the diabetic wound cream or silver sulphadiazine cream as a thin layer. Patients were advised to do dressing daily, either in the out patient clinic of our hospital or nearby local hospital or with the aid of the community nurse who provides home care for patients with ambulatory problems.
Duration of ulcer before enrollment in the study and the number of days taken for healing of the wound were recorded. Offloading of the wounds was done by standard method in both the groups. Clinical outcome was documented as a part of routine practice. Healing was defined as complete epithelialization either by secondary intention or by split skin graft.
Statistical analysis: SPSS package (version 10.0) was used for doing statistical analysis. Mean±SD for continuous variables and proportions were reported as relevant. Student's ‘t’ test, Chi-square test and Friedman's non parametric repeated measures comparison were used to test the significance, and P<0.05 was considered significant.