A Prospective, Randomized, Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy...
Venous Leg UlcersTo test safety and efficacy of Bacteriophage on Venous Leg Ulcers.
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Varicose UlcerIndividuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months. Secondary outcomes are: time to healing of all ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the number of weeks patients were free from ulcers, function, pain, and health related quality of life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics result in better healing rates, more cost-effective care, and improved client and provider satisfaction than the home visiting model.
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
Pressure UlcersVenous Ulcers3 moreThe clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology. The indications for use are: partial and full-thickness wounds pressure ulcers venous ulcers diabetic ulcers chronic vascular ulcers tunneled/undermined wounds trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
Community RCT of the Effectiveness of Two Compression Bandaging Technologies
Venous UlcerLeg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Venous UlcersThe aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Venous Leg UlcerVenous Stasis UlcerThis study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy. Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Venous Leg UlcerVenous Stasis UlcersThis is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.
Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU
Varicose VeinsVeins Diseases1 moreThis is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device. The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients...
Venous Leg UlcerDiabetic Foot UlcerThis study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Chronic WoundVenous Leg Ulcer1 moreA prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.