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

NCT07480447 | Not Yet Recruiting

• 1 other identifier: 21/RC/KEMU
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Chronic Wounds; Pain Reduction; Nanofat Grafting; Autologous fat grafting

Outcome Measures

Primary Outcomes (1)

• Reduction in Mean Pain Score in Patients With Chronic Wounds

  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

Study Arms (2)

Fat Grafting Plus Standard Wound Care

EXPERIMENTAL

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

Standard Wound Care Alone

ACTIVE COMPARATOR

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

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.

Also known as: Nano-Fat Injection, Autologous Adipose Tissue Grafting

Fat Grafting Plus Standard Wound Care

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.

Standard Wound Care Alone

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead

MeSH Terms

Conditions

Wounds and Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosiate Professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03