NCT05241704

Brief Summary

The aim of this trial is to determine if fat grafting may have applicability to venous ulcers by comparing healing and recurrence rates in patients who receive combined fat grafting and endovenous ablation with patients who receive endovenous ablation only

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

January 24, 2022

Last Update Submit

February 15, 2022

Conditions

Varicose Ulcer

Keywords

venous, ulcers, fat graft, adipose, stem cells

Outcome Measures

Primary Outcomes (1)

  • Time to ulcer healing

    Defined as time needed for complete re-epithelialisation with no dressing required post procedure

    12 weeks

Secondary Outcomes (7)

  • Ulcer healing rates

    12 weeks

  • Recurrence rates

    1 year

  • Incidence of adverse events

    1 year

  • Visual Analog Score for pain

    1 year

  • The Aberdeen Varicose Vein Questionnaire (AVVQ)

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Endovenous ablation of superficial venous reflux + Fat grafting

EXPERIMENTAL

Endovenous ablation of the main truncal venous reflux to the lowest point of incompetence, where possible (routine practice) + Fat grafting

Procedure: Fat graftingProcedure: Endovenous ablation of superficial venous reflux

Endovenous ablation of superficial venous reflux only

ACTIVE COMPARATOR

Endovenous ablation of the main truncal venous reflux to the lowest point of incompetence, where possible (routine practice)

Procedure: Endovenous ablation of superficial venous reflux

Interventions

Fat graftingPROCEDURE

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 ulcer under complete aseptic operative setting

Endovenous ablation of superficial venous reflux + Fat grafting
Endovenous ablation of superficial venous refluxPROCEDURE

Endovenous ablation of the main truncal venous reflux to the lowest point of incompetence, where possible (routine practice)

Endovenous ablation of superficial venous reflux + Fat graftingEndovenous ablation of superficial venous reflux only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or more.
  • Able to provide written informed consent.
  • Chronic venous ulcers (C6 on CEAP classification).
  • Superficial venous disease diagnosed on venous duplex.
  • Ankle-brachial pressure index (ABPI) of 0.8 or more.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galway University Hospital

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Varicose UlcerUlcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Elsharkawi

    University College Hospital Galway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elsharkawi

CONTACT

+353873989378dr_easterny@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 16, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)