Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers

Stopped early · Phase 3

Conditions studied: Chronic Diabetic Foot Ulcers

In brief

A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

Key facts

Study ID

NCT02571738

Run by

Osiris Therapeutics

People needed

108

Starts

2015-10-01

Expected to finish

2017-06-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 years and 80 years of age inclusive, as of the date of screening
• Confirmed diagnosis of Type I or Type II Diabetes
• An Index Ulcer defined as chronic (presence of wound for > 4 weeks), but not present for more than 52 weeks at the Screening Visit
• Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
• The Index Ulcer is between 1 cm2 and 15 cm2, inclusive, at the Screening Visit
• The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
• Wound is free of necrotic debris
• Patient has adequate circulation to the foot as documented by either:
• Ankle Brachial Index (ABI) > 0.70 and < 1.30, or
• In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50, or
• In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing).

You may not qualify if…

• Index Ulcer is of non-diabetic pathophysiology
• Gangrene is present on any part of the affected foot
• Index Ulcer is over an active Charcot deformity
• The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
• Patient is currently receiving dialysis or planning to go on dialysis
• Patient has had 2 or more previous disease-related amputations of the lower extremities
• Patient has a glycated hemoglobin A1c (HbA1c) level of >10%
• Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
• Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
• Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
• Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
• Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
• Patient has active malignancy other than non-melanoma skin cancer
• Patient's Index Ulcer has decreased by ≥20% during 1-week screening period
• Patient's random blood sugar is >350 mg/dl at screening
• Patient has untreated alcohol or substance abuse at the time of screening
• Pregnant women and women who are breastfeeding
• Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
• Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
• Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
• Patients who have already been randomized in Protocol 303 at any center may not be considered for screening or for re-entry into the trial at any center, even after the end of their follow-up period
• Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol.

Where it is running

• SAVAHCS — Tucson, Arizona, United States
• ILD Research Center — Carlsbad, California, United States
• Center for Clinical Research — Castro Valley, California, United States
• Center for Clinical Research — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Barry University Clinical Research — North Miami Beach, Florida, United States
• SSH — South Weymouth, Massachusetts, United States
• Ocean County Foot & Ankle Surgical Associates — Toms River, New Jersey, United States
• NSLIJHS — Lake Success, New York, United States
• UNC — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University Orthopedics — Altoona, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• North Texas Podiatric Medicine and Surgery Associates — Dallas, Texas, United States
• Texas Gulf Coast Medical Group — Webster, Texas, United States

Full record on ClinicalTrials.gov

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