Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Platelet Rich fibrin: PRF will be done weekly in concerned ulcer for four weeks
Control Intervention1: Platelet Rich Plasma: Platelet Rich Plasma will be done weekly in concerned ulcer
Sponsors
Chahat Bansal
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine the effect of PRF compared to PRP by evaluating the healing rate at end of 4 weeks Percentage area reduction in ulcer area at 1 week 2 weeks 3 weeks 4 weeks in both groups Adverse events in both groups Timepoint: 1 week 2 week 3 week 4 week | — |
Countries
India
Contacts
Public ContactSrikumarV
AIIMS, New Delhi
Outcome results
None listed