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A study to see how a person s own blood components, along with a plaster cast that takes pressure off the wound, can help foot wounds heal in people with diabetes.

Role of Platelet-Rich Fibrin and Off-Loading in Diabetic Foot Ulcer Management: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098437
Enrollment
144
Registered
2025-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Platelet rich Fibrin application followed by Offloading with Total Contact Cast application: Baseline assessment of Diabetic foot ulcer will be done including recording of dimensions an

Sponsors

ICMR- Investigator Initiated Projects-Small Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient having Diabetes Mellitus with a foot ulcer. Age of patient between eighteen to seventy five years. Presence of Diabetic Foot ulcer of Wagner staging one and two. Patient should be haemodynamically stable and presence of no fever. Platelet count more than one point five lakh per milliliter blood. Haemoglobin more than eleven gram per decilitre blood. Patient must give consent to take part in study.

Exclusion criteria

Exclusion criteria: Presence of vascular insufficiency- ruled out by Doppler study. Presence of severe Anaemia, Thrombocytopenia, Coagulation disorders, Cardiac disorders, history of Malignancy. Presence of Febrile Illness. Pt on immunosuppressants / anticoagulants. Uncontrolled Diabetes Positive Viral Markers. Under treatment for any Psychiatric issues (failure to comply and follow up). Not willing to participate

Design outcomes

Primary

MeasureTime frame
Reduction of surface area and volume of the wound Reduction of PUSH score Improvement of wound as per Wagner staging Timepoint: At baseline First week Second week Third week Fourth week Fifth week Sixth week Second month Third month Fourth month Fifth month Sixth month Eighth month Tenth month Twelfth month

Secondary

MeasureTime frame
Improvement in Quality of life using WHOQOL BREF scale Improvement of lower limb function using Lower Extremity Functional scale Reduction of burden on caregiver using Modified Caregiver strain index scale Timepoint: At baseline First week Second week Third week Fourth week Fifth week Sixth week Second month Third month Fourth month Fifth month Sixth month Eighth month Tenth month Twelfth month

Countries

India

Contacts

Public ContactDr Arvind Kumar Sharma

All India Institute of Medical Sciences, Raebareli

arvindkgmu25@gmail.com6388930133

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026