Lipofilling for Healing of Chronic Wounds

Wound Healing Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509673
• Other study ID #: 2010-001
• Status: Completed
• Phase: N/A
• Start date: June 29, 2011
• Est. completion date: March 6, 2017

Study information

• Verified date: August 2022
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 6, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing Disorder
• Wounds and Injuries

Intervention

Other:
• Lipofilling (sublesional fat grafting)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Witten/Herdecke	Cologne-Merheim Medical Center (CMMC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Bacterial contamination wound	Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention	3 weeks