Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
STRIDE 5
Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")
1 other identifier
interventional
261
1 country
21
Brief Summary
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 12, 2017
December 1, 2017
Same day
April 23, 2013
December 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment
2.5yrs
Other Outcomes (2)
Changes from baseline in laboratory evaluations (clinically significant changes)
2.5yrs
Proportion of all subjects treated and terminating prematurely due to adverse events related to study treatment.
2.5yrs
Study Arms (1)
0.03% DSC127 topical gel
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female ambulatory subjects who are at least 18 years of age at screening
- Have at least one ulcer:
- chronic ( present \>1month)
- Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and not involving bone, tendon or capsule (probing to tendon or capsule) and/or penetrating to tendon or capsule.)
- with no sign of infection or osteomyelitis, and
- is located below the malleolus.
- Have an ABI \> 0.7, or have a TcPO2 \> 40 mm Hg or great toe systolic pressure \> 50 mmHg to ensure healing potential.
- Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to study enrollment.
- Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period.
- Female subjects of child-bearing 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, double barrier, or abstinence during the treatment periods of study participation.
- 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 study medication components.
- Exposure to any investigational product within 30 days of entry into study.
- Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years.
- Chronic liver dysfunction evidenced by transaminase levels \> 2.5 times higher than the upper level of normal on two occasions.
- Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G)
- Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
- Prior radiation therapy of the foot with the ulcer under study.
- Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study
- Sickle-cell anemia, Raynaud's or other peripheral vascular disease.
- Subjects receiving a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the 7 days prior to exposure to DSC127.
- Subject who, in the opinion of the investigator, has uncontrolled hypertension
- Subject has an ulcer which is determined to be clinically infected and requires antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7 days for any reason. (Subjects with infection at the initial visit of the Screening Period can be re-screened three weeks later after a single course of antibiotic therapy (occurring concurrently - within three weeks of the initial visit, the antibiotic treatment must have completed and some washout (7 days) must have elapsed); if after that time infection is still present, the subject will be excluded.)
- Subjects who, in the opinion of the investigator, have clinically significant anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Integriumcollaborator
Study Sites (21)
WILMAX Clinical Research
Mobile, Alabama, 36608, United States
Reliance Institute of Clinical Research
Chino, California, 91710, United States
Roy O. Kroeker, DMP, Inc.
Fresno, California, 93710, United States
Limb Preservation Platform (LPP)
Fresno, California, 93720, United States
Foot and Ankle Clinic
Los Angeles, California, 90010, United States
Center for Clinical Research, Inc.
San Francisco, California, 94115, United States
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
Orange County Research Center
Tustin, California, 92780, United States
Advanced Research Institute of Miami
Homestead, Florida, 33030, United States
UF Health Orthopaedic Surgery Clinic
Jacksonville, Florida, 32209, United States
Phoenix Medical Research, LLC
Miami, Florida, 33165, United States
Miami Dade Medical Research Institute
Miami, Florida, 33176, United States
GF Professional Research
Miami Lakes, Florida, 33016, United States
Barry University Clinical Research
North Miami Beach, Florida, 33169, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713, United States
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834, United States
O'Malley Foot and Ankle
Wilmington, North Carolina, 28411, United States
Martin Foot & Ankle
York, Pennsylvania, 17402, United States
Carolina Musculoskeletal Institute
Aiken, South Carolina, 29801, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Professional Education and Research Institute
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Caminis, MD
Integra LifeSciences Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
December 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 12, 2017
Record last verified: 2017-12