Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05241704 |
| Other study ID # |
117/12 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2022 |
| Est. completion date |
July 2023 |
Study information
| Verified date |
February 2022 |
| Source |
National University of Ireland, Galway, Ireland |
| Contact |
Mohamed Elsharkawi |
| Phone |
+353873989378 |
| Email |
dr_easterny[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Study design:
This is a randomised, prospective, active-control pilot study to compare the effectiveness of
fat grafting combined with endovenous ablation to endovenous ablation alone on wound healing
in patients with venous ulcers in a tertiary vascular care centre. This study will randomise
20 patients with venous ulcers in an equal ratio to one of two treatment arms. The
intervention arm will be randomised to undergo endovenous ablation of superficial venous
reflux combined with fat grafting at the same setting. The control arm will be offered
endovenous ablation only. All patients in both arms will receive compression therapy until
full ulcer healing. They will then be followed up in the outpatient clinic every 4 weeks to
record wound size and to monitor any adverse events.
Study setting:
Potential participants will be identified, screened and randomised at the vascular outpatient
clinics within the Saolta group university hospitals, Ireland. Patients in both arms will
receive the intervention in operating theatre in Roscommon University Hospital (RUH). Fat
grafting will be performed under the supervision of a plastic surgeon. The coordinating
centre will be the Department of Vascular and Endovascular Surgery, University College
Hospital Galway (UCHG), and the School of Medicine at the National University of Ireland
Galway (NUI Galway).
Study screening:
Patients with chronic venous ulcers will be invited to join the study. Researchers will
screen the patient for inclusion and exclusion criteria. Invited patients will be provided
with a pre-designed information leaflet. This leaflet will be fully explained to the patient
at the initial assessment. The study researchers will answer any questions about the study.
Informed consent will be obtained from the patient on a formatted consent form. Patients will
be given the freedom to give consent either on the same day or later.
Baseline visit:
Patients will undergo detailed clinical assessment by the researcher as part of the baseline
evaluation. Recorded assessments will include:
- Demographics
- General clinical details (ABPI, comorbidities, medication history)
- Ulcer details (location, duration, size, progression, previous ulcer history). If the
patient has multiple venous ulcers, we will only report on the largest of these ulcers
as the index ulcer.
- Details of venous disease (previous deep vein thrombosis, previous venous interventions,
pattern of venous reflux on duplex)
- Assessment of Clinical, Etiologic, Anatomic, Pathophysiological (CEAP) score via
performing venous duplex scan.
- Disease specific and quality of life assessment scores
Sample size:
There are currently no previous studies from which we can withdraw a power calculation for
this trial. Previous studies on the use of fat grafting have looked at fat grafting as a sole
intervention. To our knowledge there are no studies that have combined both endovenous
ablation and fat grafting. As such this study is designed as a pilot study. The proposed
sample size for this pilot study is 20 patients, being randomised to 10 patients in each arm.
Randomisation:
After meeting the inclusion criteria, screened patients will be randomised to one of two
treatment arms. The intervention arm will receive fat grafting combined with endovenous
ablation. The control arm will be offered endovenous ablation only. This is an intention to
treat designed study, where patients are analysed as randomised. Each screened patient will
be given a unique screening number.
Sequence generation:
Screened patients will be randomised in a 1:1 ratio of study intervention: control according
to a randomisation scheme. The randomisation scheme will be produced using the PROC PLAN®
procedure of the SAS® software package (version 9.2.2) using a simple randomisation strategy.
The scheme will be concealed from all patients and study personnel until after database lock.
Allocation concealment:
Patients will be allocated to intervention via a sequentially numbered opaque sealed
envelopes, which will not deliver the randomised allocation except after registering the
subject screening number. Each screened patient who is recruited to the trial will be given a
unique patient trial number.
Blinding:
It will be impossible to blind the investigator and the patient due to the obvious difference
in the surgical approach. Outcome assessors will be blinded. However, in the event of an
adverse event outcome assessors will be unblinded.
Statistical analysis:
All data will be analysed according to the intention to treat principle. The comparison of
the primary outcomes measure (time to healing) achievement in the two arms will be performed
by using Kaplan Meier survival curves and Log rank test. Secondary outcomes will be assessed
using Chi square or Fisher's Exact, where appropriate. An exact 95% confidence interval will
be applied for the difference between intervention groups.
