Trials / Terminated
TerminatedNCT05608187
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Ilya Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year long-term follow-up period. A total of 30 subjects will be randomized to low dose of ILP100-Topical (ILP100Lo), high dose of ILP100-Topical (ILP100Hi) or Placebo according to a 1:1:1 randomization schedule. The study will consist of a 3-weeks Screening and Run-in Phase, followed by a 5-week Treatment Phase starting from Baseline and an Assessment Phase from Week 5 to Week 26. Thereafter, the subjects will be followed yearly during 5 years in a Long-Term Safety Follow-up Phase.
Conditions
- Wound Heal
- Wound Healing Disturbance of
- Wound Healing Disorder
- Wound Healing Delayed
- Diabetic Foot Ulcer
- Diabetic Foot Ulcer Mixed
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2 | Topical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 5x10\^7 CFU/cm\^2 wound area. |
| BIOLOGICAL | ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2 | Topical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 1x10\^9 CFU/cm\^2 wound area. |
| BIOLOGICAL | Placebo | Topical application of placebo (ILP100 dilution buffer mixed with the activation peptide SppIP). |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2024-12-16
- Completion
- 2024-12-20
- First posted
- 2022-11-08
- Last updated
- 2025-03-05
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05608187. Inclusion in this directory is not an endorsement.