The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation.
254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure.
The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed consent to participate.
✓. No planned hospitalization in the forthcoming 20 weeks.
✓. Male or female (women of childbearing age must have an acceptable method of birth control).
✓. Age \>18 years.
✓. Recent (less than 12 months) doppler or duplex colour ultrasonography compatible with chronic venous insufficiency.
✓. ABPI (less than 3 months) ≥0.7 for both legs. If ABPI \>1.4, then big toe pressure \>60mmHg is required or an alternative measurement verifying normal distal arterial flow.
✓. At least one or more supra- or peri-malleolar leg ulcers and no foot ulcer or another chronic wound.
✓. In case of two or more ulcers, select ulcer with the highest PUSH score at randomization and treat the non-selected ulcer in the same way as ulcers in the control group (standard of care).
Exclusion criteria
✕. Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at randomization.
✕. Wound covered fully or partially by necrotic tissue (black tissue).
✕. Patients who will have problems following the protocol, especially compression therapy.
✕. Patients included in another on-going clinical investigation, or patients who have participated in a clinical investigation during the past 30 days.
✕. Wounds treated with dressings containing an active component (e.g. silver, nanooligosaccharide factor (NOSF), charcoal, chlorhexidine, iodine or ibuprofen) 14 days prior to study enrollment.
✕. Patient with a systemic infection not controlled by suitable antibiotic treatment.
✕. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids (\>10 mg Predinsolone or equivalent) if any.