Clinical Study Of Affinity Versus SOC In The Management Of VLUs

A Prospective, Multicenter, Randomized, Controlled Clinical Study Of Affinity Versus SOC In The Management Of VLUs

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Other: Affinity

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 screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.

Subjects that are randomized into the SOC group whose VLU has not healed by week 12 may be crossed over to receive Affinity® and followed for an additional 12-14 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Galen Hale; Phone Number: (205) 541-9682; Email: GHale@organo.com
• Study Contact Backup: Name: Andrea Black; Phone Number: (781) 830-2364; Email: ABlack@organo.com

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92009
      • Recruiting
      • ILD Research
      • Contact: Eric Martinez; Email: eric@ildresearch.com
      • Principal Investigator: Dean Vayser, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
3. Venous insufficiency ulcers between 2 cm2 and 80 cm2
4. 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.
5. Subjects are between 18 and 85 years of age.
6. IRB approved Informed Consent Form is signed before screening and treatment.
7. Subject is expected to be available for 24 week follow-up
8. Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator.
9. Subjects with bilateral ulcers may be enrolled.

Exclusion Criteria:

1. Ankle Brachial Index (ABI) of <0.65
2. Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
3. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
4. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
5. Signs and symptoms of infection, cellulitis, osteomyelitis
6. Necrotic or avascular ulcer beds
7. Ulcer with exposed bone, tendon or fascia
8. Subjects receiving hemodialysis or have uncontrolled diabetes
9. 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.
10. Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.
11. Subject is pregnant or breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Affinity plus SOC; 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; Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).
No Intervention: Standard of Care (SOC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of time that a wound achieves complete wound closure (CWC)	Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups	12 weeks
Greater than 40% wound closure at week 4 from baseline	Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline	4 weeks
VLU improvement by or on End of Study (EOS) from baseline	Defined by >60% reduction in area, or >60% reduction in depth, or >75% reduction in volume	24 weeks
Incidence of ulcer recurrence	Number of recurrent ulcers	24 weeks
Mean number of ulcer free days	Average number of ulcer free days	24 weeks

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Study Director: Christine McLennan, Organogenesis Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: VLU; Chronic Venous Leg Ulcer; Non-healing VLU
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 20-VLU-003-AFF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No