Comparison of Pain Reduction in Painful Chronic Wounds With and Without Fat Grafting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorKing Edward Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• Active wound infection.
Wounds due to malignancy or irradiation.
Pregnant or lactating females
Smokers
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous Fat Grafting
Procedure/SurgeryParticipants 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/SurgeryParticipants 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Fat Grafting Plus Standard Wound CareExperimental treatment 1 intervention
Group B: Standard Wound Care AloneActive comparator 1 intervention
Trial outcomes
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.
Time frame
21 days post-treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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