The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
- Metabolic Disorder
- Type 1 Diabetes Mellitus
- Diabetic Complication
- Type 2 Diabetes Mellitus
- United Kingdom
- United States
NCT02833389 2015-003283-36 GX29915
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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.
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
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com