The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
Diabetic Foot UlcerVenous Leg UlcerThis study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use. Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.
Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease
Peripheral Arterial DiseaseChronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs
Pressure and Temperature Sensor for Therapeutic Compression Garments
Healthy AdultsVenous Leg UlcerPilot study of a soft, flexible pressure and temperature sensor
Clinical Trial of Footwear in Patients With Diabetes
AmputationsDiabetes1 moreA Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear. Other investigators report similar findings for injurious footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation. A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72% of patients who resume wearing their own footwear compared to 26% of patients who continued wearing "prescribed" footwear. A Swedish cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear components. In a German diabetic population the reulceration rate was 87% in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who continued to wear their custom shoes. Unfortunately, none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor did these studies address patient adherence to prescribed footwear; thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested.
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Venous or Mixed Leg UlcersPost-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
Safety Follow-Up to HP 802-247-09-015
Venous Leg UlcerVenous Stasis UlcerThis is a 24-week observational follow safety study for Study 802-247-09-015.
Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
Leg UlcerThis study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.
Clinical Investigation of Sorbact® Dressings
Hard-to-heal WoundsDiabetic Foot Ulcer3 moreThe main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
Diabetic FootFoot Ulcer3 moreThe primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).
Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
Chronic Leg UlcersPrimary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.