A prospective study of platelet derived growth factor in wound healing of diabetic foot ulcers in Indian population

INTRODUCTION: DM is a state of chronic hyperglycaemia producing complications like neuropathy,nephropathy and retinopathy.It is also a strong co factor in causing atherosclerotic disease and dyslipidemia. The microvascular and macrovascular complication prevalence is 46% and 64% respectively. Diabetes is the commonest cause of non traumatic lower extremity amputations. It has been reported that annually, about 1 to 4 percent of those with diabetes develop a foot ulcer. Invariably the diabetic foot ulcers are chronic ulcers that are resistant to heal because of multidrug resistant organism growth and microvascular complications. Recent advances in concept of wound healing and the factors and cell types involved in wound healing have opened a pathway for curing chronic ulcers. PDGF is one among the growth factors important in angiogenesis and regeneration that is used in treating chronic ulcers. PDGF are derived from platelets which contain alpha and beta granules. The rh-PDGF is produced by recombinant DNA process by inserting the human gene for the B chain of the Growth Factor in the yeast saccharomyces cevisiae. AIM OF THE STUDY: 1. To evaluate the efficacy of PDGF over saline dressing in healing of diabetic ulcers of the foot. 2. To compare and analyze the distribution of Diabetic ulcers of the Foot with age, sex, location of the ulcer (plantar or dorsum). MATERIALS AND METHODS: Study design: Prospective Randomized controlled trial. Source of Data: Patients with diabetic foot ulcers admitted in surgery wards at PSG Hospitals over a period from August 2011 to August 2012. Sample Size: 50 patients, 25-patients -in the study group, 25-patients -in the control group. Inclusion criteria: 1. Age between 20 and 80 yrs. 2. Diabetic ulcers located below the ankle. 3. Diabetic ulcers of the leg-Grade 1 and 2 (Wagner classification). 4. Size of ulcer less than 10x10 cm [length X breath]. Exclusion criteria: 1. Poor sugar control (HbA1c >12%), 2. Patients with severe Anaemia (<7gm/dl), 3. Diabetic ulcers grade 3, 4 and 5 (Wagner classification). METHOD: The present study was carried out at PSG Hospitals, Coimbatore, for a period of one year, where 50 patients with diabetic foot ulcers were included in the present study. Using a pretested and predesigned proforma the study population was randomized into either study group or control group using an open label randomization technique. Out of 50, patients, 25 took treatment in the form of conventional normal saline dressings and 25 took treatment with rh-PDGF dressing once a day. Glycaemic control and adequate control of infection was maintained in both the groups. If culture grows organism, both control and study group cases would be treated with antibiotics as per culture sensitivity report.X-ray foot was taken for all patients and bony involvement was excluded. The initial area measurement was taken on day 01 and final area measurement on day 15 was taken on transparent sheet. Plannimetry was used to measure the outcome that is the target ulcer area using a transparent graph sheet. Results were calculated by using student “t” test. CONCLUSION: The wounds in the study group treated with rh-PDGF dressing contracted more than the wounds in the control group (38.55% Vs. 12.79%; P = < 0.001- Statistically Significant) which indicates rh-PDGF dressing is an effective modality to facilitate wound contraction in patients suffering from diabetes. Rh-PDGF dressing is found to be more effective, safe promoter of wound healing and can be used as an adjunct to saline dressings for healing of diabetic wounds