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

NCT07480447 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Wound and Injuries
  • Pain

Interventions

PROCEDURE

Autologous Fat Grafting

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.

PROCEDURE

Standard Wound Care

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.

Sponsors & Collaborators

  • King Edward Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-05-01
Completion
2026-11-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07480447 on ClinicalTrials.gov