Fat Grafting in Reducing Recurrence in Patients With Healed Venous Ulcers A Prospective Randomised Clinical Pilot Study

NCT05239416 | Unknown

• 1 other identifier: 118/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators aim to use fat grafting in patients with previously healed venous ulcers to study its role on increasing skin thickness and reconstructing skin layers which was damaged by venous hypertension and determine its impact on reducing recurrence rates at 1 year

Conditions

Varicose Ulcer

Keywords

venous, ulcers, fat graft, adipose, stem cells

Outcome Measures

Primary Outcomes (1)

• Patient's quality of life post fat grafting

  Chronic Lower Limb Venous Insufficiency Questionnaire - 14 (CIVIQ-14)

  1 year

Secondary Outcomes (5)

• Skin thickness changes

  1 year

• Recurrence rates

  1 year

• Time to recurrence

  1 year

• Incidence of adverse events

  1 year

• Pain severity scores

  1 year

Study Arms (2)

Fat grafting combined with compression therapy

EXPERIMENTAL

Fat grafting + compression bandages/stockings Fat grafting: For the purposes of this study, the standard technique will be used for all patients * General or local anaesthesia. * Performed under the supervision of a plastic surgeon. * Harvest site will be either abdomen or lower limb. * After harvesting fat by liposuction, the lipoaspirate (which contains the ASCs) will be injected at the base of the healed venous ulcer within the same aseptic operative setting. Compression therapy: compression bandages / stockings as per routine practice

Procedure: Fat grafting

Compression therapy only

NO INTERVENTION

Compression therapy: compression bandages / stockings as per routine practice

Interventions

Fat grafting PROCEDURE

Under general or local anaesthesia, fat will be harvested from either abdomen or lower limb. After harvesting the fat by liposuction, the lipoaspirate will be injected underneath the healed ulcer area under complete aseptic operative setting

Fat grafting combined with compression therapy

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or more.
• Able to provide written informed consent.
• Healed primary venous ulcers (C5 on CEAP classification) of 5cm or less for at least 1 month.
• Ankle-brachial pressure index (ABPI) of 0.8 or more.

You may not qualify if:

• Healed recurrent venous ulcers
• Evidence of deep venous occlusion
• Malignancy or immune-suppression
• Malnutrition
• Multi-organ failure
• Pregnancy

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

Mohamed Elsharkawi

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Elsharkawi

  University College Hospital Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elsharkawi

CONTACT

+353873989378; dr_easterny@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 14, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)