Clinical trial NCT02958072: LeucoPatch in Malleoli Ulcer Study
Official title: LeucoPatch in Malleoli Ulcer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Malleoli Ulcers
Malleoli Ulcers
Keywords: Malleoli ulcers
Diabetes
Healing
Dressing
LeucoPatch
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Reapplix
name: Skane University Hospital
First posted: 2016-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm²
* Foot ulcer duration more than 6 weeks
* No need for arterial revascularisation- as judged by the Investigator
* informed consent

Exclusion Criteria:

* Hemoglobin concentration under 6.5 mmol/l screening
* Non-compliant with blood-letting
* Clinically infected ulcer
* Patient planned for or has had a revascularization procedure in the affected leg within the last 8 weeks
* The ulcer have been treated with growth factors in the last 8 weeks
* History of deep venous insufficiency, chronic venous leg ulcer or stasis dermatitis
* Breast-feeding women or fertile women not agreeing to use an effective method of contraception
* Participation in another clinical ulcer-healing study within the last 4 weeks
* Patient has previously been randomized in this study
* Judgement by the investigator that the patient is not able to participate in the study

Primary outcomes:
measure: Healing of malleoli ulcer (YES/NO)
timeFrame: up to 24 weeks of treatment
Secondary outcomes:
measure: Time to healing of malleoli ulcer
timeFrame: 24 weeks
measure: Ulcer area reduction based on Image J measured on acetate drawing
timeFrame: 24 weeks
measure: Health related quality of life questionnaire SF12
timeFrame: week 0, week 12, and week 24
measure: Health related quality of life questionnaire EQ-5D
timeFrame: week 0, week 12, and week 24
measure: Pain at ulcer location
timeFrame: week 0, week 6, week 12 and week 24
measure: Z scores of combined plasma concentration of growth factors, cytokines and inflammatory markers
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kobenhavn
country: Denmark
facility: Bispebjerg hospital
state: Region Hovedstaden
city: Viborg
country: Denmark
facility: Viborg Sygehus
state: Region Midt
city: Hillerod
country: Denmark
facility: Nordsjaellands Hospital
state: Regionh
city: Herlev
country: Denmark
facility: Herlev-Gentofte Hospital
city: Kolding
country: Denmark
facility: Kolding Sygehus
city: Lund
country: Sweden
facility: Skaane University Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Lise Tarnow, Professsor
role: STUDY_DIRECTOR
References: