Comparison of Pain Reduction in Painful Chronic Wounds With and Without Fat Grafting

Sponsor
King Edward Medical University
Study ID
NCT07480447
Status
Not Yet Recruiting

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Conditions

  • Pain
  • Wound and Injuries

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Fat Grafting — PROCEDURE
    Participants will receive autologous fat grafting in addition to standard wound care. Fat will be harvested from the patient's thigh using the Coleman technique, processed into nano-fat through sequential filtering and centrifugation, and injected into the wound bed and margins. The injection volume is approximately 0.4 cc per cm² along wound edges and 0.6 cc per cm² within the wound bed. After injection, wounds will be dressed with tulle gauze, with dressing changes every 48-72 hours. Pain will be assessed using the Visual Analog Scale (VAS) three times daily for 21 days. Wound size, healing percentage, and complications, including infection, will also be monitored. Rescue analgesia (IV Toradol 0.5 mg/kg) will be administered if VAS \> 3.
  • Standard Wound Care — PROCEDURE
    Participants will receive standard wound care without fat grafting. Wounds will be cleaned with povidone-iodine and dressed with tulle gauze and a secondary cotton gauze layer. Dressing changes will occur every 48-72 hours. Pain will be assessed using the VAS three times daily for 21 days. Wound size, healing percentage, and complications, including infection, will also be monitored. Rescue analgesia (IV Toradol 0.5 mg/kg) will be administered if VAS \>3.

Study Details

Chronic wounds, such as those caused by diabetes, burns, or poor blood circulation, often heal slowly and can cause significant pain, affecting daily life and quality of life. This study aims to evaluate whether autologous fat grafting-a procedure in which a patient's own fat tissue is injected into the wound-can reduce pain and improve healing in chronic wounds compared to standard care without fat grafting. We will enroll 62 adult patients with chronic wounds lasting more than 3 months. Participants will be randomly assigned to two groups: one group will receive fat grafting along with standard wound care, and the other group will receive standard wound care alone. Pain will be measured using a Visual Analog Scale (VAS) over 21 days after treatment. Wound healing and any complications will also be monitored. The results of this study will help determine if autologous fat grafting is an effective and safe method to reduce pain and improve recovery in patients with chronic wounds.

Key Dates

First listed
Mar 18, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fat Grafting Plus Standard Wound Care
    Participants in this arm will receive autologous fat grafting in addition to standard wound care. Fat will be harvested from the patient's thigh using the Coleman technique, processed into nano-fat through sequential filtering and centrifugation, and injected into the wound bed and margins. The typical volume is approximately 0.4 cc per cm² along wound edges and 0.6 cc per cm² within the wound bed. Wounds will be dressed with tulle gauze, with dressings changed every 48-72 hours. Pain, wound size, and wound healing will be monitored for 21 days, with rescue analgesia provided if VAS \> 3.
  • Active Comparator: Standard Wound Care Alone
    Participants in this arm will receive standard wound care alone without fat grafting. Wounds will be cleaned with povidone-iodine and dressed with tulle gauze and cotton gauze layers. Dressings will be changed every 48-72 hours. Pain, wound size, and wound healing will be monitored for 21 days, with rescue analgesia provided if VAS \>3.

Primary Outcome Measure

Reduction in Mean Pain Score in Patients With Chronic Wounds [ Time Frame: 21 days post-treatment ]

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