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

March 14, 2026 updated by: Farrukh Aslam, King Edward Medical University

Comparison of Pain Reduction in Chronic Wounds Treated With and Without Autologous Fat Grafting: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic wounds are a common problem, particularly in patients with diabetes, vascular diseases, or post-traumatic injuries, and are associated with significant pain, delayed healing, and increased healthcare costs. Pain in chronic wounds can be both background and procedural, affecting quality of life and sometimes leading to psychosocial complications. Current treatments include surgical and non-surgical interventions, such as tulle dressings, interactive dressings, skin substitutes, and negative pressure wound therapy. However, these approaches may be costly, require frequent dressing changes, or have limited availability, particularly in lower-middle-income countries.

Autologous fat grafting has emerged as a promising technique to promote wound healing due to the high content of stem cells and growth factors in adipose tissue. Recent studies suggest that fat grafting not only accelerates tissue regeneration but may also reduce pain associated with chronic wounds. Limited data exist regarding its efficacy specifically for pain reduction in chronic wounds.

This randomized controlled trial will enroll 62 adult patients (ages 20-60) with chronic wounds persisting for more than 3 months and with a baseline mean VAS pain score >3. Participants will be randomly assigned to one of two groups: Group A (fat grafting plus standard wound care) or Group B (standard wound care alone). Wound cleansing will be performed in both groups using povidone-iodine. In Group A, autologous fat will be harvested using the Coleman technique, processed into nano-fat through sequential filtering and centrifugation, and injected into the wound bed and margins. In Group B, wounds will be managed with standard tulle gauze dressings. Dressings in both groups will be changed every 48-72 hours.

Pain will be assessed using the Visual Analog Scale three times daily for 21 days, and the mean daily pain score will be calculated. Wound healing percentage, wound size, and any complications, including infection, will be documented. Rescue analgesia (IV Toradol 0.5 mg/kg) will be provided if the VAS score exceeds 3. Data will be analyzed using SPSS v26, with appropriate statistical tests applied to compare pain reduction and wound healing between groups.

The study aims to provide evidence on the effectiveness and safety of autologous fat grafting for reducing pain and improving outcomes in patients with chronic wounds, potentially informing future clinical practice and management strategies for this patient population.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 3 months old chronic wound (Venous arterial, traumatic, burn and diabetic) having mean VAS Pain score >3 at rest

    • Wound area between 4 cm² to 10 cm²
    • Aged 20-60 years.
    • Both male and female

Exclusion Criteria:

  • • Active wound infection.

    • Wounds due to malignancy or irradiation.
    • Pregnant or lactating females
    • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Nano-Fat Injection
  • Autologous Adipose Tissue Grafting
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Mean Pain Score in Patients With Chronic Wounds
Time Frame: 21 days post-treatment
Pain will be assessed using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). The mean pain score will be calculated for each patient three times daily (8:00 am, 2:00 pm, and 8:00 pm) over the 21-day post-treatment period. The primary outcome is the change in mean VAS pain score from baseline to post-treatment in patients receiving autologous fat grafting compared to those receiving standard wound care.
21 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/RC/KEMU (Other Identifier: King Edward Medical Univerity)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Autologous Fat Grafting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe