Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

Inclusion Criteria for DFU:

Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.

• Subjects must be at least 18 years of age or older.

• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.

• At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.

• 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.

• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

• The target ulcer must be Wagner 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.

• 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.

• 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.

• The subject must consent to using the prescribed off-loading method for the duration of the study.

• The subject must agree to attend the weekly study visits required by the protocol.

• The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria for DFU:

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.

• A subject known to have a life expectancy of < 6 months is excluded.

• The subject is excluded if the target ulcer is not secondary to diabetes.

• If the target ulcer is infected or if there is cellulitis in the surrounding skin.

• If there is evidence of osteomyelitis complicating the target ulcer.

• Subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.

• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.

• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.

• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.

• 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).

• 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.

• A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).

• A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

• Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.

• A subject with end stage renal disease requiring dialysis is excluded.

• A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.

• A subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

• A subject with a known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics is excluded.

• Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

Inclusion Criteria for VLU:

Potential subjects are required to meet all the following criteria for enrollment in the study.

• Subjects must be at least 21 years of age or older.

• At randomization subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.

• 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.

• No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.

• 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.

• If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.

• 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.

Exclusion Criteria for VLU:

Potential subjects meeting any of the following criteria will be excluded from enrollment in the study.

• The potential subject is known to have a life expectancy of < 6 months.

• The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.

• The target ulcer exposes tendon or bone.

• 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 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 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 (SV-1) to the TV-1 visit during which time the potential subject received SOC.

• Women who are pregnant or considering becoming pregnant within the next 6 months.

• The potential subject has end stage renal disease requiring dialysis.

• Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

• A potential subject who, 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.

• The subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.

• A subject has a wound with active or latent infection is excluded.

• A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.

• A subject with a known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics is excluded.