Status:
UNKNOWN
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
Lead Sponsor:
Organogenesis
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 u...
Detailed Description
Two hundred (200) subjects with a chronic VLU ranging in size from 2cm2 and 80 cm2 will be randomized 1:1 to either Affinity® and SOC or SOC alone following the 28 day screening period. Following scre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04901013
Start Date
June 14 2021
End Date
June 1 2023
Last Update
September 8 2021
Active Locations (1)
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1
ILD Research
Carlsbad, California, United States, 92009