LeucoPatch in Malleoli Ulcer Study

NCT ID: NCT02958072

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2023-11-30

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.

Conditions

Diabetic Malleoli Ulcers; Malleoli Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LeucoPatch

Treatment with usual ulcer care and LeucoPatch once weekly up til 24 weeks or until healing.

Group Type: EXPERIMENTAL

LeucoPatch

Intervention Type: OTHER

LeucoPatch is an fully autologous growth factor-containing dressing

Usual care followed by LeucoPatch

Usual care weekly for 12 weeks, if the ulcer persist after the12 weeks LeucoPatch treatment will be started for up to 12 weeks or until healing.

Group Type: ACTIVE_COMPARATOR

LeucoPatch

Intervention Type: OTHER

LeucoPatch is an fully autologous growth factor-containing dressing

Interventions

LeucoPatch

LeucoPatch is an fully autologous growth factor-containing dressing

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reapplix

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lise Tarnow, Professsor

Role: STUDY_DIRECTOR

Nordsjaellands Hospital

Locations

Bispebjerg hospital

Copenhagen, Capital Region, Denmark

Viborg Sygehus

Viborg, Region Midt, Denmark

Nordsjaellands Hospital

Hillerød, Regionh, Denmark

Herlev-Gentofte Hospital

Herlev, , Denmark

Kolding Sygehus

Kolding, , Denmark

Skaane University Hospital

Lund, , Sweden

Countries

Denmark; Sweden

Other Identifiers

LiDMUS

Identifier Type: -

Identifier Source: org_study_id