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

NCT ID: NCT01830348

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-12-31

Brief Summary

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.

Detailed Description

Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization, providing they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.

All aspects of Standard of Care are followed throughout the study period.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DSC127

DSC127 0.03% in a vehicle gel (hydroxyethyl cellulose (HEC) with parabens)

Group Type: ACTIVE_COMPARATOR

DSC127

Intervention Type: DRUG

DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner

Vehicle gel

Vehicle gel comprising HEC with parabens

Group Type: PLACEBO_COMPARATOR

placebo vehicle gel

Intervention Type: DRUG

Interventions

DSC127

DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner

Intervention Type: DRUG

placebo vehicle gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female ambulatory subject age ≥18 years at the time of informed consent

2. 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

3. 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 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.

4. Has an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer

5. Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.

6. 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.

7. 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

Exclusion Criteria

1. Has a known hypersensitivity to any of the investigational drug or vehicle components

2. Has been exposed to any investigational agent within 30 days of entry into the study

3. A female who is pregnant or nursing

4. 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.

5. Has a hemoglobin of less than 8.5 gm/dL.

6. Transaminase levels greater than 3 × normal

7. Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy

8. Has had prior radiation therapy of any part of the foot with the target ulcer under study

9. Use of systemic corticosteroids and immunosuppressants (within the 8 weeks prior to screening)

10. Has an ulcer primarily ischemic in etiology

11. Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease

12. Has received a biologic agent, growth factors or skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days

13. Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening.

14. Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene

15. Has uncontrolled hypertension, in the opinion of the Investigator.

16. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrium

INDUSTRY

Sponsor Role: collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gere S diZerega, MD

Role: STUDY_DIRECTOR

Integra LifeSciences Corporation

Locations

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

Countries

United States

Other Identifiers

DSC127-2012-01

Identifier Type: -

Identifier Source: org_study_id