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")

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: 0.03% DSC127 topical gel

Detailed Description

All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first.

If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria.

For the entire duration of each treatment period the standard of care for DFU will be maintained.

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • WILMAX Clinical Research
  • California
    • Chino, California, United States, 91710
      • Reliance Institute of Clinical Research
    • Fresno, California, United States, 93710
      • Roy O. Kroeker, DMP, Inc.
    • Fresno, California, United States, 93720
      • Limb Preservation Platform (LPP)
    • Los Angeles, California, United States, 90010
      • Foot and Ankle Clinic
    • San Francisco, California, United States, 94115
      • Center for Clinical Research, Inc.
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Homestead, Florida, United States, 33030
      • Advanced Research Institute of Miami
    • Jacksonville, Florida, United States, 32209
      • UF Health Orthopaedic Surgery Clinic
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute
    • Miami, Florida, United States, 33165
      • Phoenix Medical Research, LLC
    • Miami Lakes, Florida, United States, 33016
      • GF Professional Research
    • North Miami Beach, Florida, United States, 33169
      • Barry University Clinical Research
    • Saint Petersburg, Florida, United States, 33713
      • Professional Health Care of Pinellas
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Eastern Carolina Foot & Ankle Specialists
    • Wilmington, North Carolina, United States, 28411
      • O'Malley Foot and Ankle
  • Pennsylvania
    • York, Pennsylvania, United States, 17402
      • Martin Foot & Ankle
  • South Carolina
    • Aiken, South Carolina, United States, 29801
      • Carolina Musculoskeletal Institute
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Professional Education and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female ambulatory subjects who are at least 18 years of age at screening

2. Have at least one ulcer:

   1. chronic ( present >1month)
   2. 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.)
   3. with no sign of infection or osteomyelitis, and
   4. is located below the malleolus.
3. Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential.
4. 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.
5. 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.
6. 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.
7. 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 study medication components.
2. Exposure to any investigational product within 30 days of entry into study.
3. 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.
4. Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than the upper level of normal on two occasions.
5. 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)
6. Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
7. Prior radiation therapy of the foot with the ulcer under study.
8. Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study
9. Sickle-cell anemia, Raynaud's or other peripheral vascular disease.
10. 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.
11. Subject who, in the opinion of the investigator, has uncontrolled hypertension
12. 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.)
13. Subjects who, in the opinion of the investigator, have clinically significant anemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.03% DSC127 topical gel	Drug: 0.03% DSC127 topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment	2.5yrs

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Integrium
• Investigators: Study Director: John Caminis, MD, Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 25, 2013

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; plantar neuropathic ulcer; plantar neuroischemic ulcer; Wagner Grade 1 or Grade 2 DFU
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: DSC127-2012-05