Diabetic Malleoli Ulcers, Malleoli Ulcers
Conditions
Keywords
Malleoli ulcers, Diabetes, Healing, Dressing, LeucoPatch
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.
Interventions
OTHERLeucoPatch
LeucoPatch is an fully autologous growth factor-containing dressing
Sponsors
Reapplix
Skane University Hospital
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of malleoli ulcer (YES/NO) | up to 24 weeks of treatment | Confirmed by a blinded observer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer area reduction based on Image J measured on acetate drawing | 24 weeks | — |
| Health related quality of life questionnaire SF12 | week 0, week 12, and week 24 | Short Form 12 questionnaire (quality of life)SF-12 |
| Time to healing of malleoli ulcer | 24 weeks | Weeks from Inclusion to Wound healing |
| Pain at ulcer location | week 0, week 6, week 12 and week 24 | VAS Score (Visual Analogue Scale) |
| Z scores of combined plasma concentration of growth factors, cytokines and inflammatory markers | 24 weeks | — |
| Health related quality of life questionnaire EQ-5D | week 0, week 12, and week 24 | Euroquol-D5 questionnaire(mood and function) EQ-5D |
Countries
Denmark, Sweden
Outcome results
None listed