Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02958072 |
| Other study ID # |
LiDMUS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2016 |
| Est. completion date |
November 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Nordsjaellands Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
An International Multicenter study evaluation, off the effect of the fully autologous growth
factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers.
To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic
settings, versus usual care in the same clinics on malleoli ulcers healing.
Description:
Diabetic Foot Ulcers are a common and severe complication, that affects Patients Life
Quality. Healing time is often long and the Diabetic foot ulcer is the dominating not
traumatic reason for leg amputation.
Treatment of a diabetic foot ulcer requires debridement, offloading, regularly foot care,
specially tailored shoes, antimicrobial treatment, and sometimes even surgical interventions.
Despite all these interventions the diabetic foot ulcer may not heal.
Malleoli ulcers in patients without diabetes share several features of pathogenesis and lack
of healing potentials with the Diabetic Ulcer. Like the features of pathogenesis and lack of
healing potential and are therefore included in this study.
Research has shown that other methods such as Growth factors may be a way to enhance the
chance of healing.
Growth Factors have been shown to have a positive effect in studies, but no products that are
characterized as autologous have as yet obtained positive results in controlled studies.
LeucoPatch is produced solely from a patient´s own blood without addition, and is autologous.
LeucoPatch appears as an elastic membrane and can be fitted to the individual ulcer.
LeucoPatch is shown to contain as many or more growth factors as existing products, and has a
high concentration of fibrin, platelets and leukocytes.
A non-controlled study was made on ulcers less than 10cm 2 and 52% had competed
epithelization after 20 weeks. An International randomized multicenter trial is ongoing to
evaluate the efficacy and safety of LeucoPatch on healing of hard to heal diabetic foot
ulcers below the malleoli.
This Study is designed to test the healing effect of the LeucoPatch on malleoli ulcers, the
Patient will be randomized and the healing will be confirmed by a blinded observer.
