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

NCT01849965 | Terminated Phase 3

• 1 other identifier: DSC127-2012-02
• Study Type: interventional
• Target: 396
• Locations: 4 countries
• Sites: 56

Brief Summary

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.

Conditions

Diabetic Foot Ulcers

Keywords

diabetic foot ulcers; Wagner Grade 1 or 2 ulcers

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed 2 weeks later) after initiation of treatment.

  Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs vehicle control.

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

Secondary Outcomes (1)

• The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed two weeks later) after initiation of treatment.

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

Other Outcomes (3)

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

  Measurements to ten weeks post first dose

• Percent reduction in target ulcer area per week.

  Up to ten weeks post first dose

• Incidence of and time to target ulcer recurrence after confirmed complete wound closure has been established.

  To a maximum of 24 weeks post first dose

Study Arms (3)

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

Standard of Care gel

PLACEBO COMPARATOR

Aquasite gel, as standard of care gel

Drug: Standard of Care gel, Aquasite

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 occurs sooner.

DSC127

placebo vehicle gel DRUG

Vehicle gel

Standard of Care gel, Aquasite DRUG

Standard of Care 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 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 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.

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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Integrium: collaborator

Study Sites (56)

East Valley Foot and Ankle Specialist

Mesa, Arizona, 85206, United States

Location

Arizona Burn Center Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Associated Foot & Ankle Specialists, PC

Phoenix, Arizona, 85015, United States

Location

Ledesma Foot and Ankle

Phoenix, Arizona, 85032, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

Location

Reliance Institute of Clinical Research

Chino, California, 91710, United States

Location

Vladimir Zeetser, DPM

Encino, California, 91316, United States

Location

Innovative Medical Technologies, LLC

Los Angeles, California, 90063, United States

Location

Samuel Merritt University, California School of Podiatric Medicine

Oakland, California, 94609, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

The Diabetic Foot and Wound Center

Denver, Colorado, 80220, United States

Location

Orthopedic Research Associates

Boynton Beach, Florida, 33472, United States

Location

Invesclinic, LLC

Fort Lauderdale, Florida, 33308, United States

Location

Research in Miami, Inc.

Hialeah, Florida, 33013, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Phoenix Medical Research

Miami, Florida, 33165, United States

Location

New Phase Clincal Trials, Inc.

Miami Beach, Florida, 33140, United States

Location

Bluegrass Foot Center c/o Research Concierge, LLC

Owensboro, Kentucky, 42303, United States

Location

Grace Research

Shreveport, Louisiana, 71101, United States

Location

American Center for Clinical Trials

Southfield, Michigan, 48034, United States

Location

Dr. Vincent Giacalone

Emerson, New Jersey, 07630, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27533, United States

Location

O'Malley Foot and Ankle

Wilmington, North Carolina, 24801, United States

Location

Regional Infectious Disease & Infusion Center Inc.

Lima, Ohio, 45801, United States

Location

Paddington Testing Clinic

Philadelphia, Pennsylvania, 19103, United States

Location

Martin Foot & Ankle

York, Pennsylvania, 17403, United States

Location

North Texas Podiatric Medicine & Surgery

Dallas, Texas, 75231, United States

Location

Bone and Joint Institute

Fort Worth, Texas, 76104, United States

Location

Houston Foot & Ankle Specialists

Houston, Texas, 77074, United States

Location

Redwood Health Center

Salt Lake City, Utah, 84119, United States

Location

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Location

Lawson Health Research Institute

London, Ontario, N6C 5J1, Canada

Location

Xceed Clinical

Whitby, Ontario, L1N 2L1, Canada

Location

Centre Podiatrique et Soins des Plaies

Boucherville, Quebec, J4B 5E4, Canada

Location

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centro de Curacion de Heridas del Caribe, Inc.

Aguadilla, 00603, Puerto Rico

Location

Office of Renier D. Gonzalez-Cruz, MD

Juana Díaz, 00795, Puerto Rico

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

Wound and Ulcer Care Clinic

San Juan, 00918, Puerto Rico

Location

GCT - Mercantile Clinical Trial Centre - Primecure Clinic

Port Elizabeth, Eastern Cape, 6020, South Africa

Location

Iatros International

Bloemfontein, Free State, 9301, South Africa

Location

Josha Research

Bloemfontein, Free State, 9301, South Africa

Location

Worthwhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

Dr Lakha's Consulting Rooms

Johannesburg, Gauteng, 1829, South Africa

Location

Newtown Clincal Research Centre

Newtown, Gauteng, 2113, South Africa

Location

Sunninghill Hospital

Sunninghill, Gauteng, 2157, South Africa

Location

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, 4001, South Africa

Location

Flamco Clinical Trials

Durban, KwaZulu-Natal, 4092, South Africa

Location

Brookedale Clinical Research Centre

Phoenix, KwaZulu-Natal, 4068, South Africa

Location

Tiervlei Trial Centre, Karl Bremer Hospital

Cape Town, Western Cape, 7530, South Africa

Location

Tread Research

Parow, Western Cape, 7505, South Africa

Location

Boland Ethical Research Group

Worcester, Western Cape, 6850, South Africa

Location

Randles Road Medical Centre

Durban, ZwaZulu Natal, 4091, South Africa

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

• Alan Dunton, 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: May 6, 2013
• First Posted: May 9, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

ZA (14); US (33); PR (4); CA (5)