Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Status unconfirmed · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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.

Key facts

Study ID

NCT04901013

Run by

Organogenesis

People needed

200

Starts

2021-06-14

Expected to finish

2023-06-01

Last updated by the study team

2021-09-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subjects with bilateral ulcers may be enrolled.

You may not qualify if…

• 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
• 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
• Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
• Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.
• Subject is pregnant or breast feeding.

Where it is running

• ILD Research — Carlsbad, California, United States (enrolling)

Full record on ClinicalTrials.gov

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