New silicone dressings show promise for chronic leg ulcers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is 18 years of age or older and has given formal written consent. * Diagnosed with a chronic, exuding lower extremity wound of a single limb: * Venous leg ulcer (VLU) or * Diabetic Foot Ulcer (DFU). * Target ulcer persists since min. 1 and max. 12 months prior to screening. * An appropriate dressing size is available to be used according to the size of the target ulcer, the ulcer size shall be no longer than 10 cm in one dimension. * Target ulcer is not clinically infected ( Clinically infected wound is defined as a wound that required the use of systemic antibiotics or topical antimicrobials ). * Ankle-brachial pressure index (ABPI) is between 0.8 and 1.2 measured during the Screening or within 30 days prior to the Screening Visit. If ABPI is \>1.2 the Toe-Brachial Index (TBI) should be \>0.6. * Presence of an ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone. * For VLU: Patient is suitable for and agrees to use compression therapy (PütterPro2 or PütterPro2 Lite) for the study duration and was using compression therapy before study inclusion. * For VLU: Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile. * For DFU: Patient is suitable and agrees to use offloading devises for the study duration. * For DFU: Patient is able to walk in conjunction to offloading devices. Ankle mobility is fully mobile to limited mobile. Exclusion Criteria: * Known allergies/hypersensitivity or intolerance to any of the study product ingredients. * Patients with ischemic diabetic foot ulcers. * Patients with more than two full-thickness lower extremity ulcers on the same limb or greater than a total of three full-thickness lower-extremity ulcers. * Target ulcer is clinically infected according to the judgement of HCP or suspected to be clinically infected that could require systemic antibiotics at the time of screening or during the study. * Treatment with local or systemic antimicrobial therapy within 7 days prior to Screening visit or during the study duration. * According to physician's assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study. * Patient suffers from active autoimmune disease requiring corticosteroid treatment (\> 10 mg prednisolone equivalent/day) and/or other immunosuppressive (e.g. cyclosporine (\>10mg/kg), methotrexate (\>10mg/week), TNF inhibitors (e.g. infliximab) and/ or chemotherapy within 7 days prior to Screening visit or during the study duration. * Application of topical steroids to the ulcer surface 7 days prior to treatment or during the course of the study. * Hyperbaric treatment 7 days prior to treatment or during the course of the study. * Bioengineered tissue product usage on the target ulcer four weeks prior to treatment or during the course of the study. * Patients with clinically significant intermittent claudication (the symptoms significantly impact a person's ability to walk and perform daily activities). * Patients where the full dimensions of their leg ulcer could not be measured (it must be possible to display the entire wound area on one photo from a distance of 25-30 cm). * Wound is caused by malign tumor (primary or metastasis). Any malignancy within the past three years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. * History of radiation to the target ulcer site within 12 months prior to screening. * Patients with known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV). * Recurrent ulcer (the target ulcer has re-occurred within 12 months after its complete closure). * Patients with NYHA Class IV congestive heart failure (CHF). * Patients with hypertensive leg ulcers (Ulcus cruris hypertonicum Martorell). * Patient suffers from septic phlebitis, severe deep vein thrombosis (phlegmasia cerulea dolens) or other conditions posing a contraindication for compression therapy according to established guidelines and local procedures (e.g. significant sensory neuropathy). * In addition to study product, further products in direct contact to wound surface will be used. * Documented history of osteomyelitis at the target ulcer location within six months preceding the screening visit. * Patients with oedema that cannot be controlled with compression therapy. * Patient suffers from poorly controlled diabetes (Hb1Ac ≥ 8.6%) measured within 3 months before screening or at the time of screening visit. * Patient suffered from significant malnutrition with reduced serum albumin levels - serum albumin concentration is below 3.5 g/dL measured within 2 weeks before screening or at the time of screening visit. * Patients with a known history of alcohol use disorder and substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) within the past year. * Participation in any interventional study in the last 7 days before beginning of this study. * Patients with severe obesity (BMI\>40) that limited their mobility. * Female patients of childbearing age not using contraception, pregnancy (suspected or confirmed), or breast-feeding women.