Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

NCT06999590 | Recruiting Phase 4

• 1 other identifier: TIGERTAIL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

Conditions

Pressure Ulcer; Ulcer; Ulcer, Pressure; Pressure Injury

Outcome Measures

Primary Outcomes (1)

• Complete closure

  To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.

  1-20 Weeks

Secondary Outcomes (4)

• Time to Closure

  1-20 weeks

• Percentage Area Reduction

  1-20 weeks

• Determine Quality of Life

  1-20 weeks

• Adverse Events

  1-20 weeks

Study Arms (3)

ACApatch™ + SOC

EXPERIMENTAL

Human amniotic membrane tissue allografts derived from human placental tissue.

Other: ACApatch™

caregraFT™ + SOC

EXPERIMENTAL

Human amniotic membrane tissue allografts derived from human placental tissue.

Other: caregraFT™

Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, and ulcer moisture balance.

Other: Standard of Care

Interventions

ACApatch™ OTHER

Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

ACApatch™ + SOC

caregraFT™ OTHER

Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

caregraFT™ + SOC

Standard of Care OTHER

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance) until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• The potential subject must be at least 18 years of age or older.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
• At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post-debridement with the imaging device.
• The potential subject has adequate off-loading of the ulcer.

You may not qualify if:

• The potential subject is known to have a life expectancy of \< 3 months.
• The potential subject's target ulcer is not a pressure ulcer.
• The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• The target ulcer has undermining or tunneling.
• There is evidence of osteomyelitis complicating the target ulcer.
• The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
• The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
• The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
• The potential subject has end stage renal disease requiring dialysis.
• The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
• The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead
• ExtremityCare, LLC.: collaborator
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Serena Group

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Serena, MD

  Serena Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshdeep Kaur, MS

CONTACT

1-888-665-5005; arshdeepk@tigerbios.com

Khristina Harrel

CONTACT

1-412-212-0123; kharrell@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)