The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | November 14, 2016 |
| End Date: | November 12, 2018 |
A Phase Ib, Blinded, Randomized, Multicenter, Multiple-Ascending−Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A Administered by Subcutaneous Injection in Patients With Non-Healing Neuropathic Diabetic Foot Ulcers
This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not
respond adequately to standard wound care. Participants across multiple sites will be
assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria
and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12
weeks in addition to standard wound care.
repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not
respond adequately to standard wound care. Participants across multiple sites will be
assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria
and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12
weeks in addition to standard wound care.
Inclusion Criteria:
- Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy
- Have adequate circulation to the foot
- Have an ulcer area at screening up to 6 cm^2
- Up to date on all age-appropriate cancer screenings per local standards
Exclusion Criteria:
- Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection
- Have gangrene present on any part of the affected foot
- Known peripheral arterial disease requiring revascularization
- Have a glycated hemoglobin A1C level of greater than (>) 15% assessed at screening
- Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic
agents
- Have active malignancy or any history of a malignancy
- Use of oral antibiotics at the time of randomization for any reason in participants to
be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts
We found this trial at
11
sites
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