Clinical trial NCT06449638: Modified Platform Trial Assessing Multiple CAMPs and SOC Vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Official title: A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Ulcer Foot
Diabetic Foot
Foot Ulcer
Keywords: Cellular, Acellular, Matrix-like Product (CAMP)
Cellular and/or Tissue Product (CTP)
Dehydrated Complete Human Placental Membrane (dCHPM)
Lead sponsor: StimLabs
Sponsor class: INDUSTRY
Collaborators: name: SerenaGroup, Inc.
First posted: 2024-06-10
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CAMPSTIM employs a novel modified platform clinical trial design. CAMPSTIM will evaluate several CAMPs, specifically (4) placental-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing diabetic foot ulcers. The initial plan is to evaluate the four CAMPs identified in this protocol; however, the platform design allows for the inclusion of additional products which will be added following an interval analysis.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.

Detailed description: The CAMPSTIM trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate four separate CAMPs (Cellular, Acellular, Matrix-like Products), Revita®, Relese®, Cogenex®, and Enverse®. The study utilizes a unique modified platform trial to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
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 full thickness without exposed 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. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
   2. Toe-Brachial Index (TBI) ≥ 0.6;
   3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
   4. Pulse Volume Resistance (PVR): biphasic.
8. If the potential 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. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
11. The potential subject must agree to attend the weekly study visits required by the protocol.
12. The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. 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).
8. The potential subject is taking hydroxyurea.
9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. 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). MolecuLight 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).
13. 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 visit during which time the potential subject received SOC.
14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
16. The potential subject has end stage renal disease requiring dialysis.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
19. The target ulcer 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.
20. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutrition Assessment.

Primary outcomes:
measure: The percentage of target ulcers achieving complete wound closure
timeFrame: 1-12 weeks
Secondary outcomes:
measure: Time to closure for the target ulcer
timeFrame: 1-12 weeks
measure: Percent area reduction
timeFrame: 1-12 weeks
measure: Adverse events
timeFrame: 1-14 weeks
measure: Change in pain in target ulcer
timeFrame: 1-14 weeks
measure: Determine improvement in Quality of Life - wQOL
timeFrame: 12 weeks
measure: Determine improvement in Quality of Life - FWS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: SerenaGroup Omaha Research Center
state: Nebraska
city: Tulsa
country: United States
facility: Wound Care of Tulsa
state: Oklahoma
city: Jefferson Hills
country: United States
facility: SerenaGroup Research South
state: Pennsylvania
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: Monroeville
country: United States
facility: SerenaGroup Monroeville
state: Pennsylvania
Study officials:
References: