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NCT05509673

Lipofilling for Healing of Chronic Wounds

Completed NA Last updated 22 August 2022
What this trial tests

NA trial testing Lipofilling (sublesional fat grafting) in Wound Healing Disorder in 34 participants. Completed in 6 March 2017.

Timeline
29 June 2011
Primary endpoint
30 November 2016
6 March 2017

Quick facts

Lead sponsorUniversity of Witten/Herdecke
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingsingle
Primary purposetreatment
Enrollment34
Start date29 June 2011
Primary completion30 November 2016
Estimated completion6 March 2017

Drugs / interventions tested

Conditions studied

Sponsor

University of Witten/Herdecke

Who can join

18 and older, any sex, with Wound Healing Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
    Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378

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