Clinical Study Of Affinity Versus SOC In The Management Of VLUs

NCT04901013 | Unknown

• 1 other identifier: 20-VLU-003-AFF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.

Conditions

Venous Leg Ulcer

Keywords

VLU; Chronic Venous Leg Ulcer; Non-healing VLU

Outcome Measures

Primary Outcomes (1)

• Length of time that a wound achieves complete wound closure (CWC)

  Duration (number of days) to achieve CWC from baseline to week 24 assessed between both groups

  24 weeks

Secondary Outcomes (5)

• Length of time that a wound achieves complete wound closure (CWC)

  12 weeks

• Greater than 40% wound closure at week 4 from baseline

  4 weeks

• VLU improvement by or on End of Study (EOS) from baseline

  24 weeks

• Incidence of ulcer recurrence

  24 weeks

• Mean number of ulcer free days

  24 weeks

Study Arms (2)

Affinity plus SOC

ACTIVE COMPARATOR

Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM). Affinity is human allograft tissue that is regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by FDA 21 CFR Part 1271. Affinity may be applied as a wound covering to partial- and full-thickness acute and chronic wounds

Other: Affinity

Standard of Care (SOC)

NO INTERVENTION

Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.

Interventions

Affinity OTHER

Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).

Affinity plus SOC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

ILD Research

Carlsbad, California, 92009, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christine McLennan

  Organogenesis Inc.

  STUDY DIRECTOR

Central Study Contacts

Galen Hale

CONTACT

(205) 541-9682; GHale@organo.com

Andrea Black

CONTACT

(781) 830-2364; ABlack@organo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: June 14, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)