CTRI/2024/01/061562
Not yet recruiting
Phase 2
Efficacy of Platelet-Rich Plasma and Platelet-Rich Fibrin in Diabetic Foot Ulcer- A Randomised, parallel group active comparator trial - NI
Chahat Bansal0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Chahat Bansal
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age more than 18 years and less than 70years
- •Both male and female group
- •Documented Diagnoses of Diabetes Mellitus
- •Ulcer Characteristics
- •Ulcer size more than 0\.5cm2 and less than 20cm2
- •Ulcer site Plantar surface of foot
- •Ulcer duration more than 4 weeks
- •UTS Grade 1A 1B 1C,2A 2B or 2C
- •Ulcers with absent or mild infection according to IWGDF or IDSA grading
- •Palpable dorsalis pedis artery anterior tibial artery and posterior tibial artery or
Exclusion Criteria
- •Ulcers with moderate or severe infection according to IWGDF grading requiring active surgical debridement or intravenous antibiotics
- •Ulcers of grade 1D 2D 3A 3B 3C or 3D according to University of Texas staging for DFUs
- •Ulcers due to underlying Charcot foot
- •Ulcer on foot other than plantar surface
- •Evidence of osteomyelitis on any part of the limb
- •Evidence of gangrene on any part of the affected limb
- •Bilateral diabetic foot ulcers
- •ankle brachial index less than 0\.8 or non\-palpable ATA PTA DPA
- •haemoglobin less than 10g per dl
- •platelet count less than 150000 per dl
Outcomes
Primary Outcomes
Not specified
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