Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Foot Ulcer; Diabetic Foot Ulcer; Ulcer Foot; DFU
• Intervention / Treatment: Other: SOC; Other: SLAM + SOC

Detailed Description

XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers [13]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane [13]. The product is screened and tested in a Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds AATB criteria [13].

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bennett Rogers; Phone Number: 1008 888-960-1343; Email: brogers@serenagroups.com
• Study Contact Backup: Name: Thomas Serena; Phone Number: 814-688-4000; Email: serena@serenagroups.com

Study Locations

• United States
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Recruiting
      • Detroit Foot and Ankle
      • Contact: Lina Barman; Phone Number: 586-329-3895; Email: info@detroitfa.com
      • Contact: Phone Number: (586) 329-3895

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older,
2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. The target ulcer must be Wager 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle, provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.

7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

   1. ABI ≥ 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 40 mmHg;
   4. PVR: biphasic.
8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
9. The subject must consent to using the prescribed off-loading method for the duration of the study.
10. The subject must agree to attend the weekly study visits required by the protocol.
11. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. A subject known to have a life expectancy of < 6 months is excluded.
2. The subject is excluded if the target ulcer is not secondary to diabetes.
3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
9. The potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
10. The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
11. The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit during which time the subject received SOC.
12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
13. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
14. A potential subject with end stage renal disease requiring dialysis is excluded.
15. A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
16. A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.
17. The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.

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: Standard of Care; Other: Standard of Care Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.	Other: SOC; Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Experimental: SLAM + SOC; Single layer amniotic membrane (SLAM) + SOC	Other: SLAM + SOC; Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of target ulcers achieving complete wound closure in 12 weeks.	The percentage of target ulcers achieving complete wound closure in 12 weeks.	1-12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to heal for target ulcers.	Time to closure will be determined for each treatment group and compared to SOC.	1-12 weeks
Wound Area Reduction	Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using MolecuLight Imaging Device, and physical examination.	1-12 weeks
Adverse Events	Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).	1-14 Weeks
Change in pain in the target ulcer	Change in pain in the target ulcer assessed using the PEG (pain, enjoyment in life, and general pain) scale. [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit].	1-12 weeks
Change in quality of life	Change in quality-of-life using the wQOL(Wound Quality of Life) questionnaire [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit].	1-12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of target ulcers achieving complete wound closure	Percentage of target ulcers achieving complete wound closure in 12 weeks for subjects 65 years of age or older.	1-12 weeks
Changes in chronic inhibitory bacterial load	Changes in chronic inhibitory bacterial load (CIBL) measured using fluorescence imaging.	1-14 weeks

Collaborators and Investigators

• Sponsor: Applied Biologics, LLC
• Collaborators: SerenaGroup, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: CAMPX

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