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

NCT01830348 | Terminated Phase 3

• 1 other identifier: DSC127-2012-01
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 25

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.

Conditions

Diabetic Foot Ulcers

Keywords

diabetic foot ulcers; Wagner Grade 1 or 2 foot ulcers

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later).

  Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.

  Target ulcer must achieve complete wound closure by 10 weeks post first treatment

Secondary Outcomes (1)

• Time to the visit where the target ulcer achieves confirmed complete wound closure

  Weekly assessments to ten weeks post first treatment dose

Other Outcomes (2)

• Percent reduction in ulcer area per week (closure rate)

  Weekly ulcer tracings to calculate area of ulcer, measurements continue to ten weeks post first treatment dose

• Incidence of target ulcer recurrence, time to ulcer recurrence, and number of days target ulcer remains closed after confirmed complete wound closure has been established.

  Assessed during a 12 week durability period following the confirmation of complete wound closure

Study Arms (2)

DSC127

ACTIVE COMPARATOR

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

Drug: DSC127

Vehicle gel

PLACEBO COMPARATOR

Vehicle gel comprising HEC with parabens

Drug: placebo vehicle gel

Interventions

DSC127 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

DSC127

placebo vehicle gel DRUG

Vehicle gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Integrium: collaborator

Study Sites (25)

WILMAX Clinical Research Inc

Mobile, Alabama, 36680, United States

Location

Center for Clinical Research

Fair Oaks, California, 95628, United States

Location

Roy O Kroeker, DPM, Inc

Fresno, California, 93710, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90010, United States

Location

Brian O'Carroll, DPM, Inc.

Pismo Beach, California, 93449, United States

Location

UCLA Medical Center - Olive View

Sylmar, California, 91342, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Advanced Research Institute of Miami

Homestead, Florida, 33030, United States

Location

UF Health Orthopaedic Surgery Clinic

Jacksonville, Florida, 32209, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

GF Professional Research

Miami Lakes, Florida, 33016, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33013, United States

Location

Professional Health Care of Pinellas

St. Petersburg, Florida, 33713, United States

Location

Memorial Medical Group

Granger, Indiana, 46530, United States

Location

LaPorte Medical Group

La Porte, Indiana, 46350, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

East Carolina Foot and Ankle Specialists

Greenville, North Carolina, 27834, United States

Location

Clinical Research Center

Eugene, Oregon, 97401, United States

Location

Center for Clinical Research

Portland, Oregon, 97232, United States

Location

Carolina Musculoskeletel Institute

Aiken, South Carolina, 29801, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Fort Worth Diagnostic Clinic

Fort Worth, Texas, 76104, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

aclerastide

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Gere S diZerega, MD

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: April 12, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

US (25)