Lipofilling for Healing of Chronic Wounds

Clinical Trial to Improve Wound Healing of Chronic Lower Leg Ulcers by Autologous Transplantation of Fat Tissue

Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)

Study Overview

• Status: Completed
• Conditions: Wound Healing Disorder
• Intervention / Treatment: Other: Lipofilling (sublesional fat grafting)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
• Age of ulcer > 6 weeks
• Ulcer size >= 1 cm (minimum diameter)
• Ulcer / wound with complete destruction of the epidermis (including basement membrane)
• Patient age > 18 years
• Patient Consent

Exclusion Criteria:

• Pregnancy
• Exposed tendons, ligaments, or bone if maximum diameter > 2 mm
• Ulcer size > 10 cm
• Immediately preceding vacuum bandage therapy (< 2 weeks)
• Possibilities for correcting the cause of the ulcer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group received a fat grafting under the wound bed and into the wound edges.	Other: Lipofilling (sublesional fat grafting)
No Intervention: Control group; The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of wound area	The reduction of the wound area from intervention to 14 days and 2 month post-intervention	14 days and 2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain wound	Subjective pain level of the patient in the area of the wound, measured by the visual analogue scale pre and post intervention	2 month
Bacterial contamination wound	Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention	3 weeks

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Collaborators: Cologne-Merheim Medical Center (CMMC)
• Investigators: Principal Investigator: Oliver C Thamm, MD, PhD, University of Witten/Herdecke

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2011
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): March 6, 2017

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2010-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No