I83.0
Conditions
Interventions
Group 1: Patient with chronic wounds treated with wound contact layer ResCure® dressing (Investigational product). Dressing changes are performed at least every 4 days, treatment duration is 12 weeks.
Sponsors
Leibniz-Institut für Polymerforschung e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Written Consent • Inpatient or outpatient treatment • Area of the venous leg ulcer wound must be between 5 and 50 cm2, maximum length 10 cm • Stable, non-healing venous leg ulcers for at least 8 weeks (diagnosis by investigator) • Wound bed must be mostly free of black (necrotic) or greenish/yellowish/white tissue and films (colorimetric scale) • Willingness of the patients to accept compression therapy (compression bandage, compression stocking) defined according to the specifications of the study planning.
Exclusion criteria
Exclusion criteria: • Systemic infection not controlled by suitable antibiotic treatment • Clinical signs of a strong, critical local wound infection according to TILI-Score 2.0 or osteomyelitis • Acute deep vein thrombosis within the last 3 months • Concomitant serious co-morbid disease or poor health condition that could interfere with the anticipated 12 weeks of treatment or follow-up • Peripheral arterial occlusive disease based on an ankle brachial pressure index (ABPI) = 0.8. • In the case of media sclerosis, peripheral arterial circulatory disorder of the affected study leg must be ruled out by means of Doppler sonography of the lower leg arteries or pulse oscillography or a measurement of the toe artery pressure • Concomitant treatment with immunosuppressants, radiation therapy or high doses of oral corticosteroids (= 5 mg prednisolone equivalents , e.g. Cortisol, Cortisone, Beclomethasone, Betamethasone, Dexamethasone, Prednisolone, Prednisone, etc.) • Lack of mobility: Exclude club foot (pes equinus) • Participation of the patient in another clinical trial within the last 4 weeks before inclusion into the study • Addiction or other diseases that do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial • Pregnant or breastfeeding women • Women of childbearing potential, except women who meet the following criteria: o Regular and correct use of a contraceptive method with an error rate of < 1% per year (e.g. implants, depot injections, oral contraceptives, intrauterine device – IUD). o It should be noted that combined oral contraception - in contrast to pure progesterone preparations - has a failure rate of < 1%. With a Pearl Index < 1%, hormone contraceptive coils are safer than copper contraceptive coils o Sexual abstinence o Vasectomy of the partner • Signs that the patient is unlikely to comply with the protocol (e.g. unwillingness to cooperate, reduced life expectancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence/proportion of completely healed wounds (wound closure) measured at 12 weeks between treatment with ResCure® Dressing, and a state-of-the-art wound contact layer (Atrauman®) After 12 weeks photographic documentation and evaluation of the wound is performed. Following parameters are evaluated: wound area, wound circumference and relative area of fibrin, necrosis and granulation tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| • Size of the wound area after 12 weeks (wound healing rate) • Beginning of wound epithelialization (every 2 weeks d0, d1, d28, d42, d56, d70, d84 evaluation of wound photos) • Pain measured by the visual analog scale (VAS) o at dressing change o during treatment since the last dressing change • Quality of life (VR-12 Veterans RAND 12-Item Health Survey, VEINES-QOL Venous Insufficiency Epidemiological And Economic Study On Quality Of Life) after week 6 and week 12 of treatment compared to baseline | — |
Countries
Germany
Contacts
Public ContactSarah Torke
CSG
Outcome results
None listed