Status:
UNKNOWN
Fat Grafting in Reducing Recurrence in Patients With Healed Venous Ulcers A Prospective Randomised Clinical Pilot Study
Lead Sponsor:
National University of Ireland, Galway, Ireland
Conditions:
Varicose Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Study design: This is a randomised, prospective, active-control pilot study to compare the effectiveness of fat grafting combined with compression therapy to compression therapy alone on reducing ulc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Healed recurrent venous ulcers
- Evidence of deep venous occlusion
- Malignancy or immune-suppression
- Malnutrition
- Multi-organ failure
- Pregnancy
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05239416
Start Date
February 1 2022
End Date
July 1 2023
Last Update
February 14 2022
Active Locations (1)
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1
Mohamed Elsharkawi
Galway, Ireland