Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetic Foot Ulcers

In brief

The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.

Key facts

Study ID: NCT01830348
Run by: Integra LifeSciences Corporation
People needed: 266
Starts: 2013-02-01
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 at 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; ulcer must be predominantly on the plantar surface 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 size in response to standard of care during the two week 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.
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, and 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 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 of 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 other peripheral vascular disease
Has received a biologic agent, growth factors 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 greater 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 subject in the study.

Where it is running

WILMAX Clinical Research Inc — Mobile, Alabama, United States
Center for Clinical Research — Fair Oaks, California, United States
Roy O Kroeker, DPM, Inc — Fresno, California, United States
Foot and Ankle Clinic — Los Angeles, California, United States
Brian O'Carroll, DPM, Inc. — Pismo Beach, California, United States
UCLA Medical Center - Olive View — Sylmar, California, United States
Orange County Research Center — Tustin, California, United States
Advanced Research Institute of Miami — Homestead, Florida, United States
UF Health Orthopaedic Surgery Clinic — Jacksonville, Florida, United States
Miami Dade Medical Research Institute — Miami, Florida, United States
GF Professional Research — Miami Lakes, Florida, United States
Barry University Clinical Research — North Miami Beach, Florida, United States
Professional Health Care of Pinellas — St. Petersburg, Florida, United States
Memorial Medical Group — Granger, Indiana, United States
LaPorte Medical Group — La Porte, Indiana, United States
Boston University Medical Center — Boston, Massachusetts, United States
East Carolina Foot and Ankle Specialists — Greenville, North Carolina, United States
Clinical Research Center — Eugene, Oregon, United States
Center for Clinical Research — Portland, Oregon, United States
Carolina Musculoskeletel Institute — Aiken, South Carolina, United States
ClinSearch, LLC — Chattanooga, Tennessee, United States
Dallas VA Medical Center — Dallas, Texas, United States
Fort Worth Diagnostic Clinic — Fort Worth, Texas, United States
Endeavor Clinical Trials — San Antonio, Texas, United States
Professional Education and Research Institute — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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