Status:
TERMINATED
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Integrium
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subje...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT01840085
Start Date
December 1 2015
End Date
December 1 2015
Last Update
December 12 2017
Active Locations (21)
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1
WILMAX Clinical Research
Mobile, Alabama, United States, 36608
2
Reliance Institute of Clinical Research
Chino, California, United States, 91710
3
Roy O. Kroeker, DMP, Inc.
Fresno, California, United States, 93710
4
Limb Preservation Platform (LPP)
Fresno, California, United States, 93720