Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use (STRIDE 5)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Derma Sciences, Inc.
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Derma Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01840085
First received: April 23, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

This open-label study is designed to assess the chronic-use safety of 0.03% DSC127 gel administered on a once daily basis for up to 12 weeks per treatment period, potentially over multiple treatment periods with 4-week wash-out periods between treatment periods.


Condition Intervention Phase
Diabetic Foot Ulcer
Drug: 0.03% DSC127 topical gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")

Resource links provided by NLM:


Further study details as provided by Derma Sciences, Inc.:

Primary Outcome Measures:
  • The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment [ Time Frame: 2.5yrs ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Changes from baseline in laboratory evaluations (clinically significant changes) [ Time Frame: 2.5yrs ] [ Designated as safety issue: Yes ]
  • Proportion of all subjects treated and terminating prematurely due to adverse events related to study treatment. [ Time Frame: 2.5yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.03% DSC127 topical gel Drug: 0.03% DSC127 topical gel

Detailed Description:

The study consists of up to 4 different periods for each individual subject over the duration of the study:

A screening period, treatment periods consisting of the administration of DSC127 for up to 12 weeks, a washout period between treatment periods, and an observation period.

All subjects will complete the screening period and one or more of the other periods depending on the presence or absence of one or more ulcers, and the possible recurrence thereof. If ulcers heal during the treatment period the subjects will continue to be followed bi-weekly via phone call for follow-up. If during the follow-up (observation) period ulcers recur or new ones appear which qualify the subject to enter a new treatment cycle, a clinic visit is scheduled and a new treatment period begins. Subjects with qualifying ulcers may complete as many treatment and washout periods as required during the study period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ambulatory subjects who are at least 18 years of age at screening
  • Subjects may be enrolled with or without active ulcers.

Subjects with active ulcers at the start of the Screening Period and upon enrollment into the study, are required to have at least one chronic healing or non-healing Wagner Grade 1 or Grade 2 ulcer that fulfills all criteria. Subjects without active ulcers at the start of the Screening Period and upon enrollment into the study are required to have originated from a prior DSC127 study.

  • Have an ankle-brachial index (ABI) > 0.8 for neuropathic DFU, or have a transcutaneous oxygen pressure (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 a glycosylated hemoglobin (HbA1c) of ≤ 14%, and a serum creatinine level of ≤ 3mg/dL obtained at enrollment or within 3 months of study enrollment.
  • Female subjects of child-bearing potential must have 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 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

Exclusion Criteria:

  • Has a known hypersensitivity to any of the study medication components.
  • Exposure to any investigational agent within 28 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 torsade de pointes (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; 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840085

Contacts
Contact: Shelagh Verco, PhD 805-704-1179 sverco@dermasciences.com

Locations
United States, Alabama
WILMAX Clinical Research Recruiting
Mobile, Alabama, United States, 36608
Contact: Dale Brown    251-340-6970    ceo@wilmax.com   
Contact: Candance Jenkins    251-340-6970    candace@wilmax.com   
Principal Investigator: William Higgs, MD         
United States, Arkansas
NEA Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: David Jenkins    870-219-9865    david.jenkins@neabaptistclinic.com   
Contact: Brenda Graf    870-219-9865    Brenda.graf@neabaptistclinic.com   
Principal Investigator: James Fletcher, MD         
United States, California
Roy O. Kroeker, DMP, Inc. Recruiting
Fresno, California, United States, 93710
Contact: Mary Kroeker    559-436-8162    mem-k@pacbell.net   
Principal Investigator: Roy Kroeker, DPM         
Foot and Ankle Clinic Recruiting
Los Angeles, California, United States, 90010
Contact: Suni Allen    213-365-0793    sunigmka@aol.com   
Principal Investigator: Felix Sigal, DPM         
Olive View - UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Melissa Farley    818-364-3796    mefarley@dhs.lacounty.gov   
Contact: Wendy Arriaga    818-364-4073    warriaga@dhs.lacounty.gov   
Principal Investigator: Peter Balingit, MD         
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Madonna Nicolai, RN    714-550-9990    madonna.nicolai@ocresearchcenter.com   
Principal Investigator: Joel Neutel, MD         
United States, Georgia
Advanced Wound Management Clinic / Joseph M. Still Burn and Wound Clinic Recruiting
Augusta, Georgia, United States, 30909
Contact: Farrah Parker    706-364-2966    farrah.parker@jmsburncenters.com   
Principal Investigator: S.M. Abu Zaheed Hassan, MD         
Dr. Osh and Associates Foot & Leg Clinic/ APSMO Recruiting
Macon, Georgia, United States, 31204
Contact: Gigi Villareal    678-852-1355    apsmo.crc.osh.footleg@gmail.com   
Principal Investigator: Evaristus Oshiokpekhai, DPM         
United States, Missouri
Jefferson City Medical Group Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Dorothy Webb    573-556-7785 ext 2    dwebb@jcmg.org   
Principal Investigator: Jody McAleer, DPM         
United States, North Carolina
Eastern Carolina Foot & Ankle Specialists Recruiting
Greenville, North Carolina, United States, 27834
Contact: Christy Lennon    252-830-1000    christylennon@embargmail.com   
Principal Investigator: Christopher Gauland, DPM         
PMG Research of Wilmington Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Brettany Holt    910-815-6108    bholt@pmg-research.com   
Contact: Leah Workman    910-815-6108    lworkman@pmg-research.com   
Principal Investigator: Matthew Dzurik, DPM         
United States, Pennsylvania
Wound Institute and Research Center Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Nanci Dobson, RN, CCRP    570-961-8000    ndobsonrn@managewounds.com   
Principal Investigator: Michael Moore, MD, FACS,FACCWS         
United States, South Carolina
Carolina Musculoskeletal Institute Recruiting
Aiken, South Carolina, United States, 29801
Contact: Samantha Sonderegger    803-649-3668 ext 1016    sams@cmi.md   
Principal Investigator: Mackie Walker, DPM         
United States, Texas
Forth Worth Diagnostic Clinic Recruiting
Forth Worth, Texas, United States, 76132
Contact: Debra Bolling    817-992-2372    debo322@me.com   
Contact: Marcy Conner    817-992-2372    marcysconner@gmail.com   
Principal Investigator: Byron Conner, MD, MPH         
Sponsors and Collaborators
Derma Sciences, Inc.
Integrium
Investigators
Study Director: Gere diZerega, MD Derma Sciences, Inc.
  More Information

No publications provided

Responsible Party: Derma Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01840085     History of Changes
Other Study ID Numbers: DSC127-2012-05
Study First Received: April 23, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Derma Sciences, Inc.:
Diabetic foot ulcer
plantar neuropathic ulcer
plantar neuroischemic ulcer
Wagner Grade 1 or Grade 2 DFU

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 24, 2014