Clinical Study Of Affinity Versus SOC In The Management Of VLUs (NCT04901013) | Clinical Trial Compass
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Clinical Study Of Affinity Versus SOC In The Management Of VLUs
United States200 participantsStarted 2021-06-14
Plain-language summary
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test).
✓. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
✓. Venous insufficiency ulcers between 2 cm2 and 80 cm2
✓. Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone.
✓. Subjects are between 18 and 85 years of age.
✓. IRB approved Informed Consent Form is signed before screening and treatment.
✓. Subject is expected to be available for 24 week follow-up
✓. Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator.
Exclusion criteria
✕. Ankle Brachial Index (ABI) of \<0.65
✕. Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
✕. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
What they're measuring
1
Length of time that a wound achieves complete wound closure (CWC)
. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
✕. Signs and symptoms of infection, cellulitis, osteomyelitis
✕. Necrotic or avascular ulcer beds
✕. Ulcer with exposed bone, tendon or fascia
✕. Subjects receiving hemodialysis or have uncontrolled diabetes