An interventional study:Efficacy and safety of homologous platelet concentrate for the treatment of diabetic foot ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Self sponsored
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Time to healthy granulation tissue formation
Study Overview
Brief Summary
Diabetic ulcer is a major public heath concern. About 15% of the diabetes patients develop chronic ulcer and 25% among them undergo foot amputation due to complications of various reasons. Deficiency of various growth factors related to neo-vascularisation is one among them. Platelets concentrate are rich in many of these growth factors along with anti microbial properties. So we planned the current study to assess the efficacy in healing of the diabetic ulcer among people treated with homologous platelet concentrate in comparison with people treated with standard dressing. We also want to look into the safety of single donor homologous platelet concentrate for the treatment of diabetic ulcer and the rate of graft uptake following split skin grafting.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.persons with type1 or type2 diabetes with denovo lower extremity diabetic ulcers 2.male and female,between ages 18-95 3.ulcer of atleast 4weeks duration with post debridement free of sinus tracts and tunneling and atleast 4cms from any additional wound 4.HbA1C <12 5.Wound measurement between 0.
- •20 sqcm 6.full thickness without exposure of bone, muscle, ligament, tendon 7.the limb had to have adequate perfusion via ABI between 0.8 -1.5 8.no H/O infectious disorders in last 6 months 9.informed consent form signed.
Exclusion Criteria
- •Non pregnant and non lactating women
- •Not on suppressants and ART
- •Ulcers of venous and arterial insufficiency
- •Bleeding and Clotting disorders
- •Patients on chemo and radiotherapy.
Outcomes
Primary Outcomes
1. Time to healthy granulation tissue formation
Time Frame: Fifth day and ninth day after intervention
2. Number of debridement and dressings
Time Frame: Fifth day and ninth day after intervention
5. Adverse reactions
Time Frame: Fifth day and ninth day after intervention
3. reduction in the ulcer size
Time Frame: Fifth day and ninth day after intervention
4. SSG graft uptake
Time Frame: Fifth day and ninth day after intervention
Secondary Outcomes
- SSG graft uptake for the intervention arm(5th day, 9th day)