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

Diabetic Foot Ulcers Clinical Trial

— STRIDE 2  

Official title:

A Randomized, Double-Blind, Parallel-group, Vehicle and Standard of Care-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01849965
• Other study ID #: DSC127-2012-02
• Status: Terminated
• Phase: Phase 3
• First received: May 6, 2013
• Last updated: December 8, 2017
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2017
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 all other criteria are met. Four weeks of "blinded" randomized treatment follows the screening period, and an observation period of six weeks follows the treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed at a visit two weeks later, and at this time the subjects enters a durability assessment period of up to 12 weeks.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 396
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• DSC127
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.
• placebo vehicle gel

• Standard of Care gel, Aquasite

Locations

Country	Name	City	State
Canada	Centre Podiatrique et Soins des Plaies	Boucherville	Quebec
Canada	The Mayer Institute	Hamilton	Ontario
Canada	Lawson Health Research Institute	London	Ontario
Canada	Centre de recherche du CHUS	Sherbrooke	Quebec
Canada	Xceed Clinical	Whitby	Ontario
Puerto Rico	Centro de Curacion de Heridas del Caribe, Inc.	Aguadilla
Puerto Rico	Office of Renier D. Gonzalez-Cruz, MD	Juana Diaz
Puerto Rico	Clinical Research Puerto Rico	San Juan
Puerto Rico	Wound and Ulcer Care Clinic	San Juan
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Iatros International	Bloemfontein	Free State
South Africa	Josha Research	Bloemfontein	Free State
South Africa	Tiervlei Trial Centre, Karl Bremer Hospital	Cape Town	Western Cape
South Africa	Flamco Clinical Trials	Durban	KwaZulu Natal
South Africa	Randles Road Medical Centre	Durban	ZwaZulu Natal
South Africa	Synapta Clinical Research Centre	Durban	KwaZulu Natal
South Africa	Dr Lakha's Consulting Rooms	Johannesburg	Gauteng
South Africa	Newtown Clincal Research Centre	Newtown	Gauteng
South Africa	Tread Research	Parow	Western Cape
South Africa	Brookedale Clinical Research Centre	Phoenix	KwaZulu Natal
South Africa	GCT - Mercantile Clinical Trial Centre - Primecure Clinic	Port Elizabeth	Eastern Cape
South Africa	Sunninghill Hospital	Sunninghill	Gauteng
South Africa	Boland Ethical Research Group	Worcester	Western Cape
United States	Orthopedic Research Associates	Boynton Beach	Florida
United States	Center for Clinical Research, Inc.	Castro Valley	California
United States	Reliance Institute of Clinical Research	Chino	California
United States	North Texas Podiatric Medicine & Surgery	Dallas	Texas
United States	The Diabetic Foot and Wound Center	Denver	Colorado
United States	Dr. Vincent Giacalone	Emerson	New Jersey
United States	Vladimir Zeetser, DPM	Encino	California
United States	Invesclinic, LLC	Fort Lauderdale	Florida
United States	Bone and Joint Institute	Fort Worth	Texas
United States	Wayne Memorial Hospital	Goldsboro	North Carolina
United States	Research in Miami, Inc.	Hialeah	Florida
United States	Houston Foot & Ankle Specialists	Houston	Texas
United States	River City Clinical Research	Jacksonville	Florida
United States	Regional Infectious Disease & Infusion Center Inc.	Lima	Ohio
United States	Innovative Medical Technologies, LLC	Los Angeles	California
United States	East Valley Foot and Ankle Specialist	Mesa	Arizona
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Phoenix Medical Research	Miami	Florida
United States	University of Miami	Miami	Florida
United States	New Phase Clincal Trials, Inc.	Miami Beach	Florida
United States	Samuel Merritt University, California School of Podiatric Medicine	Oakland	California
United States	Bluegrass Foot Center c/o Research Concierge, LLC	Owensboro	Kentucky
United States	Paddington Testing Clinic	Philadelphia	Pennsylvania
United States	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	Redwood Health Center	Salt Lake City	Utah
United States	Center for Clinical Research, Inc.	San Francisco	California
United States	Grace Research	Shreveport	Louisiana
United States	American Center for Clinical Trials	Southfield	Michigan
United States	O'Malley Foot and Ankle	Wilmington	North Carolina
United States	Martin Foot & Ankle	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	Integrium

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to the visit where the target ulcer achieves confirmed complete wound closure		Measurements to ten weeks post first dose
Other	Percent reduction in target ulcer area per week.		Up to ten weeks post first dose
Other	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
Primary	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	The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed two weeks later) after initiation of treatment.	Primary endpoint of complete closure is assessed by the Principle 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 Standard of Care control.	Target ulcer must achieve complete wound closure by 10 weeks post first treatment