The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
Completed · Phase 1 · Has a placebo group
Conditions studied: Neuropathic Diabetic Foot Ulcers
In brief
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.
Key facts
- Study ID
- NCT02833389
- Run by
- Genentech, Inc.
- People needed
- 72
- Starts
- 2016-11-14
- Expected to finish
- 2018-11-12
- Last updated by the study team
- 2018-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- East Valley Foot and Ankle Specialists — Mesa, Arizona, United States
- Center for Clinical Research Inc.; i — San Francisco, California, United States
- Animas Foot and Ankle — Durango, Colorado, United States
- GF Professional Research Group Corporation — Miami Lakes, Florida, United States
- Podiatry 1st — Belleville, Illinois, United States
- Clinical Research Associates Of Central Pa , Llc — Altoona, Pennsylvania, United States
- Futuro Clinical Trials — McAllen, Texas, United States
- Endeavor Clinical Trials PA — San Antonio, Texas, United States
- 1Foot 2Foot Centre for Foot & Ankle Care PC — Suffolk, Virginia, United States
- Steven M. Waldman, SC — Wauwatosa, Wisconsin, United States
- Aalborg Universitetshospital — Aalborg, Denmark
- Bispebjerg Hospital — Copenhagen, Denmark
- Odense Universitetshospital; Endokrinologisk Afdeling — Odense, Denmark
- DRC Gyogyszervizsgalo Kozpont Kft — Balatonfüred, Hungary
- Semmelweis Egyetem — Budapest, Hungary
- Kenezy Korhaz Rendelointezet — Debrecen, Hungary
- Policlinico Universitario Campus Biomedico Di Roma; Farmacia — Rome, Lazio, Italy
- Azienda Ospedaliera Universitaria Careggi — Florence, Tuscany, Italy
- Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy
- Hospital Universitario Germans Trias i Pujol — Badalona, Barcelona, Spain
- Hospital Universitario de Donostia — Donostia / San Sebastian, Guipuzcoa, Spain
- Fundacion Hospital de Alcorcon — Alcorcón, Madrid, Spain
- Hospital Universitario Cruces — Barakaldo, Vizcaya, Spain
- Universidad Complutense de Madrid — Madrid, Spain
- Bradford Royal Infirmary — Bradford, United Kingdom
Full record on ClinicalTrials.gov
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