CompletedPhase 1/2

CHF6467 SAD and MAD in Patients With Diabetic Foot Ulcer

Bulgaria93 participantsStarted 2018-10-17

Plain-language summary

To assess the safety and tolerability of single and multiple days' topical dosing with CHF6467 in subjects with diabetic foot ulcer (DFU).

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject's written informed consent obtained prior to any study-related procedure;
✓. Male or female subject, aged 18 - 80 years (extremes inclusive), diagnosed with Type I or Type II diabetes mellitus, with glycosylated haemoglobin (HbA1c) ≤ 10%.
✓. Female subjects of non-childbearing potential (WONCBP):
✓. Female subject with childbearing potential (WOCBP): they must be using one or more of the following reliable methods of contraception during the study period and at least within 90 days after the last study drug administration:
✓. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
✓. Hormonal contraception (implantable, patch, oral).
✓. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository.
✓. Male Partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

✕. For females only: pregnant or lactating female subject, confirmed by a positive serum pregnancy test at screening and a urine test performed on Day -1.
✕. Subject with:
✕. Ulcer(s) accompanied by infected cellulitis, osteomyelitis, or clinical signs or symptoms of infection confirmed by a cultural exam made on the material taken off from the ulcer according to the technique described in the guidelines for diagnosis and management of diabetic foot infections of the Infectious Diseases Society of the Americas (IDSA) (19).
✕. Gangrene or necrosis on any part of the affected limb.
✕. Active or chronic Charcot's foot on the study limb.
✕. Planned vascular surgery, angioplasty or thrombolysis or previous revascularization procedure performed within 1 month prior to enrolment.
✕. SD only: Ulcers involving exposure of tendon, bone, or joint capsule (It is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue).
✕. Ulcer(s) of non-diabetic aetiology.

Treatment Emergent Adverse Events (TEAEs)

Timeframe: SAD: From Day 1 up to Day 28; MAD: From Day 1 up to Day 84;

NCT IDNCT04077671

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-07

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject's written informed consent obtained prior to any study-related procedure;
✓. Male or female subject, aged 18 - 80 years (extremes inclusive), diagnosed with Type I or Type II diabetes mellitus, with glycosylated haemoglobin (HbA1c) ≤ 10%.
✓. Female subjects of non-childbearing potential (WONCBP):
✓. Female subject with childbearing potential (WOCBP): they must be using one or more of the following reliable methods of contraception during the study period and at least within 90 days after the last study drug administration:
✓. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
✓. Hormonal contraception (implantable, patch, oral).
✓. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository.
✓. Male Partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

✕. For females only: pregnant or lactating female subject, confirmed by a positive serum pregnancy test at screening and a urine test performed on Day -1.
✕. Subject with:
✕. Ulcer(s) accompanied by infected cellulitis, osteomyelitis, or clinical signs or symptoms of infection confirmed by a cultural exam made on the material taken off from the ulcer according to the technique described in the guidelines for diagnosis and management of diabetic foot infections of the Infectious Diseases Society of the Americas (IDSA) (19).
✕. Gangrene or necrosis on any part of the affected limb.
✕. Active or chronic Charcot's foot on the study limb.
✕. Planned vascular surgery, angioplasty or thrombolysis or previous revascularization procedure performed within 1 month prior to enrolment.
✕. SD only: Ulcers involving exposure of tendon, bone, or joint capsule (It is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue).
✕. Ulcer(s) of non-diabetic aetiology.