Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetic Foot Ulcers

In brief

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

Key facts

Study ID: NCT01849965
Run by: Integra LifeSciences Corporation
People needed: 396
Starts: 2013-04-01
Expected to finish: 2015-12-01
Last updated by the study team: 2017-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female ambulatory subject age ≥18 years at the time of informed consent
Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL
At Screening and Baseline (prior to randomization), subject has at least one ulcer that fulfills all of the following criteria:
present for ≥1 month and ≤1 year
Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e. Wagner Grade 1 or 2.
Has no sign of infection or osteomyelitis
Plantar neuropathic ulcer - predominately be on the plantar surface (i.e. weight bearing) of the foot to ensure adequate off-loading and may include the toes
Size of the target ulcer must be 0.75-6 cm2.
Target ulcer must be non-healing as defined as <30% reduction in area in response to standard of care during the Screening Period
If more than one ulcer is present that meets the inclusion criteria, the largest one will be considered the target ulcer
If there are two ulcers of the same size that meet all criteria, the one with the higher Wagner Grade will be considered the target ulcer
If there are two ulcers of the same size and the same Wagner Grade, the one present for the longest qualifying time will be the target ulcer.
Non-target ulcers will also be treated according to standard of care (Acute Charcot Neuroarthropathy of the foot with the target ulcer must be excluded)
Has an ankle brachial index (ABI) ≥0.7 on the foot with the target ulcer.
Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.
A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening.
A female subject of childbearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, tubal ligation, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures

You may not qualify if…

Has a known hypersensitivity to any of the investigational drug or vehicle or standard of care gel components
Has been exposed to any investigational agent within 30 days of entry into the study
A female who is pregnant or nursing
Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
Has a hemoglobin of less than 8.5 gm/dL.
Transaminase levels greater than 3 × normal
Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy
Has had prior radiation therapy to any part of the foot with the target ulcer under study
Use of systemic corticosteroids and immunosuppressants (within the 8 weeks prior to screening)
Has an ulcer primarily ischemic in etiology
Has sickle-cell anemia, Reynaud's, or peripheral vascular disease
Has received a biologic agent, growth factor, or skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days
Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at Screening.
Has a Wagner Grade 3 or higher DFU, deep abscess, or gangrene
Has uncontrolled hypertension, in the opinion of the Investigator.
Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the patient in the study.

Where it is running

Arizona Burn Center Maricopa Medical Center — Phoenix, Arizona, United States
Associated Foot & Ankle Specialists, PC — Phoenix, Arizona, United States
Ledesma Foot and Ankle — Phoenix, Arizona, United States
Precision Trials — Phoenix, Arizona, United States
Center for Clinical Research, Inc. — Castro Valley, California, United States
Reliance Institute of Clinical Research — Chino, California, United States
Vladimir Zeetser, DPM — Encino, California, United States
Innovative Medical Technologies, LLC — Los Angeles, California, United States
Samuel Merritt University, California School of Podiatric Medicine — Oakland, California, United States
Center for Clinical Research, Inc. — San Francisco, California, United States
The Diabetic Foot and Wound Center — Denver, Colorado, United States
Orthopedic Research Associates — Boynton Beach, Florida, United States
Invesclinic, LLC — Fort Lauderdale, Florida, United States
Research in Miami, Inc. — Hialeah, Florida, United States
River City Clinical Research — Jacksonville, Florida, United States
Advanced Pharma CR, LLC — Miami, Florida, United States
University of Miami — Miami, Florida, United States
Phoenix Medical Research — Miami, Florida, United States
New Phase Clincal Trials, Inc. — Miami Beach, Florida, United States
Bluegrass Foot Center c/o Research Concierge, LLC — Owensboro, Kentucky, United States
Grace Research — Shreveport, Louisiana, United States
American Center for Clinical Trials — Southfield, Michigan, United States
Dr. Vincent Giacalone — Emerson, New Jersey, United States
Wayne Memorial Hospital — Goldsboro, North Carolina, United States
East Valley Foot and Ankle Specialist — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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