A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100 in Subjects with Diabetic Foot Ulcers
- Conditions
- Diabetic foot ulcers a systemic complication in diabetes mellitus type 1 or 2Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-000563-69-SE
- Lead Sponsor
- Ilya Pharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
1.Signed written informed consent.
2.Males and females aged =18 years.
3.Diagnosis of diabetes mellitus type 1 or 2.
4.HbA1c = 86 mmol/mol (= 10%) at Screening.
5.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:
•A non-interdigital wound
•Accessible for administration of IMP, wound study assessments and procedures and possible to completely cover with the primary and secondary dressing
•Persistence of the wound for at least 6 weeks at Baseline
•Assessed by the investigator to be of non-venous etiology
•Minimum full skin ulcer without undermining.
•A wound area of 0.8-5.0. cm2 after sharp or mechanical debridement at Screening
•Subjects with more than one eligible wound will have the largest, hence more clinically significant wound, selected at Screening as the index wound. Other wounds should at least be 3 cm apart and not impact the procedures or assessment of the index wound.
•During the 2-weeks between start of Run-in Phase and Baseline the wound size must not decrease by more than 30% or increase by more than 25%, which correspond to wound areas of 0.6 – 6.3 cm2, or at Screening expected by the Investigator to have a high probability for wound size changes within this range during this period.
6. Toe pressure = 20 mm Hg. If toe pressure is not available ankle pressure =50 mm Hg, to allow inclusion of subjects with ischemic wounds, while excluding subjects with critical limb ischemia.
7.Expected to comply with the study procedures, including standard of care according to the protocol during the treatment phase and/or per local practise during assessment phase and long term follow up phase including off-loading.with off-loading and follow up schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Infected index wound with clinical signs of inflammation (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
2. Confirmed osteomyelitis (as per IWGDF/IDSA 2023 guidelines) at Screening or Baseline.
3. The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing.
4.Wound duration longer than 2 years.
5.Active Charcot deformity of the study foot (i.e., foot is erythematous, warm, edematous, and is actively re-modelling).
6.Estimated eGFR <30 mL/min/1.73m2, by MDRD calculation
7.Hemoglobin concentration <100 g/L at Baseline.
8.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.
9.Has any major surgery or hospitalization planned up to Week 26.
10.Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowed.
11.Revascularization procedure in the index wound leg planned or undertaken within 8 weeks before Screening, or under investigation
12. Participation in other clinical studies or having received any investigational treatment within 1 month or at the earliest five time the half-life prior to Screening.
13.Has any disease conditions, including ulcerative dermatological disorders and vasculitis, or comorbidities which is expected to prevent the subject from participating in the study or confounding the evaluation of the safety profile and effect on wound healing of ILP100.
14.Pregnant or lactating woman.
15.Male subjects not willing to use condom to prevent pregnancy and drug exposure of a fertile female partner and refrain from donating sperm from the date of the first dose until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid.
16.Female subjects of childbearing potential unless they use a contraceptive method with a failure rate of < 1% to prevent pregnancy from the start of the Run-in Phase until negative results from Week 16 in wound swabs, skin swabs, blood and feces analyses concerning findings of L. reuteri R2LC containing the pSIP_CXCL12 plasmid. Effective contraceptive methods include:
•oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
•intrauterine device
•intrauterine system (for example progestin-releasing coil)
•vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
•bilateral tubal occlusion or hysterectomy.
Female subjects are considered of non-childbearing potential if they are pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months’ amenorrhea.
17.Inability to provide informed consent, for example due to disorders affecting cognition or communication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the safety profile of ILP100 in subjects with diabetic foot ulcers (DFU).;Secondary Objective: The secondary objectives are to compare ILP100-DP and Placebo on: <br>-Local tolerability.<br>-Effect on wound healing. <br>-Effect on incidence and severity of wound infections and use of antibiotic treatment.<br>-Effect on subject reported wound-related pain.<br>- Assess the long term safety profole of ILP100 in subjects with DFU.<br>- Investigate pharmacokenitic / pharmacodynamic characteristic of ILP100 in subject with DFU.;Primary end point(s): The primary endpoint is to compare incidence and category of IMP related, treatment procedure related, and total AEs and SAEs during 4, 8, 16 and 26 weeks after initiation of treatment with ILP100 and Placebo.;Timepoint(s) of evaluation of this end point: After subject has signed informed consent form and during participation in study until last follow-up visit.
- Secondary Outcome Measures
Name Time Method