Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in… (NCT01840085) | Clinical Trial Compass
TerminatedPhase 3
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
United States261 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment
. 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