Loading clinical trials...

Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT05608187•Ilya Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent
•Males and females aged ≥18 years
•Diagnosis of diabetes mellitus type 1 or 2
•HbA1c ≤ 86 mmol/mol (≤ 10%) at Screening
•Subjects with at least one first time or recurrent full thickness ulcer (at or below the ankle) which fulfils all of the following criteria at Screening and at the time of Baseline:
•1. A non-interdigital wound
•2. Accessible for administration of IMP, wound study assessments and procedures
•3. Persistence of the wound for at least 6 weeks at Baseline
•4. Assessed by the investigator to be of non-venous etiology.
•5. Minimum full skin ulcer without undermining, with no exposed muscle, tendon or bone
+4 more criteria

Exclusion Criteria

•Infected index wound with clinical signs of inflammation at Screening or Baseline.
•The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing
•Wound duration longer than 2 years
•Active Charcot deformity of the study foot
•Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
•Hemoglobin concentration \<100 g/L at Baseline
•Planned or ongoing treatment with corticosteroids to an equivalent dose of prednisolone \>10 mg per day or other immunosuppressive therapy, or such treatment within 4 weeks prior to Baseline
•Has any major surgery or hospitalization planned up to Week 26
•Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowed
•Ongoing treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors
+7 more criteria

Locations (2)

Department of Endocrinology, Skåne University Hospital

Lund, Sweden

Clinical Diabetes Research Unit at Uppsala University Hospital

Uppsala, Sweden

Key Dates

Start Date

September 26, 2022

Primary Completion Date

December 16, 2024

Completion Date

December 20, 2024

Last Updated

March 5, 2025

Enrollment

ACTUAL participants

Conditions

Wound HealWound Healing Disturbance ofWound Healing DisorderWound Healing DelayedDiabetic Foot UlcerDiabetic Foot Ulcer Mixed

Interventions

ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2

BIOLOGICAL

ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2

BIOLOGICAL

Placebo

BIOLOGICAL

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

NCT07372404

Wound Healing

View study

RECRUITINGNA

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

NCT07330154

Wound HealingPalatal Wound+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

Exploring if Patients Can Safely and Easily Swab Their Own Surgical Wounds at Home

An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds

HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone