Lipofilling for Healing of Chronic Wounds

Study Overview
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Brief Summary
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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)

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

Conditions
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Wound Healing Disorder

Intervention / Treatment
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* Other: Lipofilling (sublesional fat grafting)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group received a fat grafting under the wound bed and into the wound edges. | Other: Lipofilling (sublesional fat grafting)<br> <br> |
| No Intervention: Control group<br>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?
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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 |