Clinical trial NCT06453187: A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
Official title: Multicenter, Prospective, Randomized, Controlled Platform Trial Assessing Clinical Utility of Cellular, Acellular and Matrix-like Products (CAMPs) and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: SerenaGroup, Inc.
First posted: 2024-06-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Detailed description: Hard to heal Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected.

Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

Eligibility criteria: Inclusion Criteria #1: Diabetic Foot Ulcers

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. ABI between 0.7 and 1.3;
   2. TBI 0.6;
   3. TCOM 40 mmHg;
   4. 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: Diabetic Foot Ulcers

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 Pl 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.

Inclusion Criteria #2: Venous Leg Ulcers

1. Male or female 18 years of age and older.
2. Subjects having a non-healing venous leg ulcer of 4 weeks duration, and a maximum of 52 weeks of standard of care (compression), prior to the initial screening visit.
3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
4. At enrollment (TV1) Subjects' wound size is a minimum of 1 cm2 and maximum of 20 cm2 as measured post-debridement with the MolecuLight® imaging device.
5. 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 between 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 40 mmHg;
   4. PVR: biphasic.
6. 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.
7. The potential subject must consent to using the prescribed compression method for the duration of the study.
8. The potential subject must agree to attend the weekly study visits required by the protocol.
9. The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria #2: Venous Leg Ulcers

1. The potential subject is known to have a life expectancy of \< 6 months.
2. Index ulcer determined to be due to a condition other than venous insufficiency.
3. The ulcer penetrates down to muscle, tendon, or bone.
4. Presence of another venous leg ulcer within 2 cm of the index ulcer. If more than one ulcer is present on the lower extremity, the largest qualifying ulcer will be chosen as the target ulcer.
5. The ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
6. Known or suspected local skin malignancy to the index ulcer.
7. A history of radiation to the ulcer.
8. Wound duration greater than one year without intermittent closure.
9. The potential subject has end stage renal disease requiring dialysis.
10. 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).
11. If diabetic, the potential subject is taking hydroxyurea (Hydroxyurea interferes with CGM function).
12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
14. 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.
15. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutrition Assessment
16. If diabetic, the potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
17. 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). The patient must have received compression during the historical run-in period.
18. The surface area measurement of the Target ulcer decreases by 20% 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.
19. In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
20. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.
21. Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

Primary outcomes:
measure: Percentage of complete wound closure for target ulcer
timeFrame: 1-12 weeks
Secondary outcomes:
measure: Time to complete wound closure for target ulcer
timeFrame: 1-12 weeks
measure: Percentage of wound area reduction for target ulcer
timeFrame: 1-12 weeks
measure: Adverse Events
timeFrame: 1-14 weeks
measure: Changes to pain associated with the target ulcer
timeFrame: 1-14 weeks
measure: Determine improvement in Quality of Life
timeFrame: 1-14 weeks
measure: Improvement of the Forgotten Wound Score (FWS)
timeFrame: 1-14 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Phase One Clinical Trials, Inc.
state: California
city: Los Angeles
country: United States
facility: Angel City Research
state: California
city: Plant City
country: United States
facility: Denali Health Plant City, LLC
state: Florida
city: Winter Park
country: United States
facility: Health Goods Management, LLC
state: Florida
city: Saint Francis
country: United States
facility: Cheyenne County Hospital
state: Kansas
city: Monroeville
country: United States
facility: SerenaGroup
state: Pennsylvania
Study officials:
affiliation: SerenaGroup, Inc.
name: Tomas Serena, MD
role: PRINCIPAL_INVESTIGATOR
References: