Lipofilling for Healing of Chronic Wounds

NCT05509673 | Completed

• 1 other identifier: 2010-001
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Wound Healing Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain wound

  2 month

• Bacterial contamination wound

  3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group received a fat grafting under the wound bed and into the wound edges.

Other: Lipofilling (sublesional fat grafting)

Control group

NO INTERVENTION

The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges.

Interventions

Lipofilling (sublesional fat grafting) OTHER

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Cologne-Merheim Medical Center (CMMC): collaborator

Study Officials

• Oliver C Thamm, MD, PhD

  University of Witten/Herdecke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Digital analysis of wound area is masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: June 29, 2011
• Primary Completion: November 30, 2016
• Study Completion: March 6, 2017
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share