To compare the effect between two types of dressing obtained from plasma of the patient in foot ulcer in diabetic patients.

Phase 2

Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Registration Number: CTRI/2024/01/061562

Lead Sponsor: Chahat Bansal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

ABI more than0.8 or duplex ultrasound with biphasic waveform below the knee and preserved peak systolic velocity

No planned revascularization procedure or vascular surgery with the last or next 30 days from the day of eligibility screening

Plantigrade foot

Subjects and caregivers willing and able to comply with all the study procedures and visits and has reasonable expectations of completing the study

Informed Consent

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

Chronic kidney disease with eGFR less than 30 ml per min per 1.73m2 or Urine albumin creatinine ratio of more than 300 mg per g

Presence of varicosities or deep vein thrombosis in the affected limb

immunodeficiency

coagulopathies

Active malignancy

Chronic steroid use or immunosuppressive agents within the last 3 months prior to enrolment

Pregnancy

Participation in another study pertaining to advanced wound closure product

Use of growth factor therapy autologous platelet-rich plasma gel dermal substitute negative pressure wound therapy within two weeks of study enrolment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ulcer area will be analysed & a percentage of the healed ulcer area will be calculated in respect to the original ulcer areaTimepoint: 1 week 2 week 3 week 4 week

Secondary Outcome Measures

Name	Time	Method
To determine the effect of PRF compared to PRP by evaluating the healing rate at end of 4 weeks <br/ ><br>Percentage area reduction in ulcer area at 1 week 2 weeks 3 weeks 4 weeks in both groups <br/ ><br>Adverse events in both groups <br/ ><br>Timepoint: 1 week 2 week 3 week 4 week