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Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Primary Purpose

Venous Leg Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Affinity

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring VLU, Chronic Venous Leg Ulcer, Non-healing VLU

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Subjects with bilateral ulcers may be enrolled.

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
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.

Sites / Locations

ILD ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Affinity plus SOC

Standard of Care (SOC)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Greater than 40% wound closure at week 4 from baseline

Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline

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

Incidence of ulcer recurrence

Number of recurrent ulcers

Mean number of ulcer free days

Average number of ulcer free days

Full Information

NCT ID

NCT04901013

First Posted

May 20, 2021

Last Updated

September 7, 2021

Sponsor

Organogenesis

1. Study Identification

Unique Protocol Identification Number

NCT04901013

Brief Title

Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 14, 2021 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organogenesis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

Keywords

VLU, Chronic Venous Leg Ulcer, Non-healing VLU

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Affinity plus SOC

Arm Type

Active Comparator

Arm Description

Arm Title

Standard of Care (SOC)

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Affinity

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Description

Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups

Time Frame

12 weeks

Title

Greater than 40% wound closure at week 4 from baseline

Description

Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline

Time Frame

4 weeks

Title

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

Description

Defined by >60% reduction in area, or >60% reduction in depth, or >75% reduction in volume

Time Frame

24 weeks

Title

Incidence of ulcer recurrence

Description

Number of recurrent ulcers

Time Frame

24 weeks

Title

Mean number of ulcer free days

Description

Average number of ulcer free days

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Subjects with bilateral ulcers may be enrolled. 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Galen Hale

Phone

(205) 541-9682

GHale@organo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Black

Phone

(781) 830-2364

ABlack@organo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine McLennan

Organizational Affiliation

Organogenesis Inc.

Official's Role

Study Director

Facility Information:

Facility Name

ILD Research

City

Carlsbad

State/Province

California

ZIP/Postal Code

92009

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Martinez

eric@ildresearch.com

First Name & Middle Initial & Last Name & Degree

Dean Vayser, DPM

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study Of Affinity Versus SOC In The Management Of VLUs

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