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Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

NCT05608187 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-03-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Jan Apelqvist, MD/PhD · Department of Endocrinology, Skåne University Hospital, Malmö, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-12-16
Completion
2024-12-20

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608187 on ClinicalTrials.gov