Phase 2
Completed N=78
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
Foot Ulcer, Diabetic · Diabetic foot
Source: ClinicalTrials.gov NCT00796744 ↗
Enrolled (actual)
78
Serious AEs
16.7%
Results posted
Sep 2012
Primary outcomePrimary: The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage. — 8; 14; 8 number of ulcers healed
Summary
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage. |
8; 14; 8 | — |
| SECONDARY The Proportion of Subjects in Each Treatment Group Reporting Adverse Events. |
23; 26; 28; 5; 4; 4 | — |
| SECONDARY The Rate of Re-epithelialization of the Ulcer Site. |
10.5; 14.3; 9.0 | — |
| SECONDARY The Time to Re-epithelialization of the Ulcer Site. |
16.5; 12.4; 17.3 | — |
Eligibility Criteria
Inclusion Criteria
- Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.
- ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU
- TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg
- Type I or Type II diabetes under metabolic control
- Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study
Exclusion Criteria
- Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
- Chronic renal insufficiency and/or chronic liver dysfunction
- Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
- Malignancy of any kind
- Receiving hemodialysis or CAPD
- Current history of drug abuse, and/or known to be HIV positive
- Prior radiation therapy of the foot under study
- Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days
- Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason
- Sickle-cell anemia, Raynaud's or other peripheral vascular disease
- Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis
- An EKG with a marked baseline prolongation of QT/QTc interval
Data sourced from ClinicalTrials.gov (NCT00796744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.