NCT Number: NCT05509673
Lipofilling for Healing of Chronic Wounds
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)
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Reduction of wound area
Time frame: 14 days and 2 month
The reduction of the wound area from intervention to 14 days and 2 month post-intervention
Secondary outcomes
-
Pain wound
Time frame: 2 month
Subjective pain level of the patient in the area of the wound, measured by the visual analogue scale pre and post intervention
-
Bacterial contamination wound
Time frame: 3 weeks
Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention
Sponsors and collaborators
Lead sponsor
University of Witten/Herdecke
Other
Collaborators
- Cologne-Merheim Medical Center (CMMC)
Registry information
Official study title
Clinical Trial to Improve Wound Healing of Chronic Lower Leg Ulcers by Autologous Transplantation of Fat Tissue
Important dates
- Study start
- 2011
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Aug 22, 2022
- Registry last updated
- Aug 22, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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