Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
This trial is active, not recruiting.
|Condition||diabetic foot ulcer|
|Treatment||0.03% dsc127 topical gel|
|Sponsor||Derma Sciences, Inc.|
|Start date||June 2013|
|End date||June 2016|
|Trial size||200 participants|
|Trial identifier||NCT01840085, DSC127-2012-05|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Mobile, AL||WILMAX Clinical Research||no longer recruiting|
|Chino, CA||Reliance Institute of Clinical Research||no longer recruiting|
|Fresno, CA||Limb Preservation Platform (LPP)||no longer recruiting|
|Fresno, CA||Roy O. Kroeker, DMP, Inc.||no longer recruiting|
|Los Angeles, CA||Foot and Ankle Clinic||no longer recruiting|
|San Francisco, CA||Center for Clinical Research, Inc.||no longer recruiting|
|Sylmar, CA||Olive View - UCLA Medical Center||no longer recruiting|
|Tustin, CA||Orange County Research Center||no longer recruiting|
|Homestead, FL||Advanced Research Institute of Miami||no longer recruiting|
|Jacksonville, FL||UF Health Orthopaedic Surgery Clinic||no longer recruiting|
|Miami Lakes, FL||GF Professional Research||no longer recruiting|
|Miami, FL||Miami Dade Medical Research Institute||no longer recruiting|
|Miami, FL||Phoenix Medical Research, LLC||no longer recruiting|
|North Miami Beach, FL||Barry University Clinical Research||no longer recruiting|
|St. Petersburg, FL||Professional Health Care of Pinellas||no longer recruiting|
|Greenville, NC||Eastern Carolina Foot & Ankle Specialists||no longer recruiting|
|Wilmington, NC||O'Malley Foot and Ankle||no longer recruiting|
|York, PA||Martin Foot & Ankle||no longer recruiting|
|Aiken, SC||Carolina Musculoskeletal Institute||no longer recruiting|
|San Antonio, TX||Endeavor Clinical Trials||no longer recruiting|
|Roanoke, VA||Professional Education and Research Institute||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment
time frame: 2.5yrs
Male or female participants at least 18 years old.
- 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
|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")|
|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.|
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