Usefulness of platelet concentrate dressing for the healing of diabetic foot ulcers

Recruiting

• Conditions: Patients with diabetic foot ulcers

• Registration Number: CTRI/2018/04/013411
• Lead Sponsor: Self sponsored

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-23
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

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 0.5.
• 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 2.
• Not on suppressants and ART 3.
• Ulcers of venous and arterial insufficiency 4.
• Bleeding and Clotting disorders 5.
• Patients on chemo and radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to healthy granulation tissue formation	Fifth day and ninth day after intervention
2. Number of debridement and dressings	Fifth day and ninth day after intervention
5. Adverse reactions	Fifth day and ninth day after intervention
3. reduction in the ulcer size	Fifth day and ninth day after intervention
4. SSG graft uptake	Fifth day and ninth day after intervention

Secondary Outcome Measures

Name	Time	Method
SSG graft uptake for the intervention arm	5th day, 9th day

Trial Locations

Locations (1)

Pondicherry; 🇮🇳 Pondicherry, PONDICHERRY, India

Pondicherry

🇮🇳Pondicherry, PONDICHERRY, India

Srinivas Gedala

Principal investigator

7538881301

srinivasgdl1@gmail.com