RecruitingNot Applicable

Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

United States150 participantsStarted 2024-10-25

Plain-language summary

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects are 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
✓. Subject history of Type I or Type II Diabetes Mellitus requiring oral glycemic control and/or insulin replacement therapy.
✓. Subjects with the following ulcer:
✓. Objectively, less than 20% healing in the two-week screening period prior to randomization.
✓. Study ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 post-debridement at first treatment visit
✓. Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
✓. The subject is able and willing to follow the protocol requirements.
✓. Subject has signed informed consent.

✕. Subject has a documented life expectancy of \< 1 year.
✕. Index ulcer has been present for \>1 year.
✕. Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
✕. Subject is unable to comply with offloading device.
✕. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
✕. Subject has ulcers that are completely necrotic or fibrotic tissue.
✕. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
✕. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.

Wound Closure Assessment Verified with Independent Adjudication

Timeframe: 12 weeks

Percentage Area Reduction verified with Independent Adjudication

Timeframe: 12 weeks

NCT IDNCT06572839

SponsorCapsicure, LLC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-10-31

Marissa Docter, RN, BSN, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects are 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
✓. Subject history of Type I or Type II Diabetes Mellitus requiring oral glycemic control and/or insulin replacement therapy.
✓. Subjects with the following ulcer:
✓. Objectively, less than 20% healing in the two-week screening period prior to randomization.
✓. Study ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 post-debridement at first treatment visit
✓. Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
✓. The subject is able and willing to follow the protocol requirements.
✓. Subject has signed informed consent.

✕. Subject has a documented life expectancy of \< 1 year.
✕. Index ulcer has been present for \>1 year.
✕. Patient does not have adequate 2-week historical data demonstrating \< 20% area reduction.
✕. Subject is unable to comply with offloading device.
✕. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
✕. Subject has ulcers that are completely necrotic or fibrotic tissue.
✕. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
✕. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.