Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Drug: 0.03% DSC127 topical gel
- Registration Number
- NCT01840085
- Lead Sponsor
- Integra LifeSciences Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 261
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 0.03% DSC127 topical gel 0.03% DSC127 topical gel -
- Primary Outcome Measures
Name Time Method The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment 2.5yrs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Orange County Research Center
🇺🇸Tustin, California, United States
WILMAX Clinical Research
🇺🇸Mobile, Alabama, United States
GF Professional Research
🇺🇸Miami Lakes, Florida, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Reliance Institute of Clinical Research
🇺🇸Chino, California, United States
Limb Preservation Platform (LPP)
🇺🇸Fresno, California, United States
Center for Clinical Research, Inc.
🇺🇸San Francisco, California, United States
Phoenix Medical Research, LLC
🇺🇸Miami, Florida, United States
Professional Education and Research Institute
🇺🇸Roanoke, Virginia, United States
Roy O. Kroeker, DMP, Inc.
🇺🇸Fresno, California, United States
Eastern Carolina Foot & Ankle Specialists
🇺🇸Greenville, North Carolina, United States
O'Malley Foot and Ankle
🇺🇸Wilmington, North Carolina, United States
Advanced Research Institute of Miami
🇺🇸Homestead, Florida, United States
Olive View - UCLA Medical Center
🇺🇸Sylmar, California, United States
Foot and Ankle Clinic
🇺🇸Los Angeles, California, United States
UF Health Orthopaedic Surgery Clinic
🇺🇸Jacksonville, Florida, United States
Professional Health Care of Pinellas
🇺🇸Saint Petersburg, Florida, United States
Barry University Clinical Research
🇺🇸North Miami Beach, Florida, United States
Martin Foot & Ankle
🇺🇸York, Pennsylvania, United States
Carolina Musculoskeletal Institute
🇺🇸Aiken, South Carolina, United States