What is this study of VULNOFAST plus and VULNOLIGHT evaluating for diabetic foot infections?

This study is evaluating whether adding the VULNOFAST plus system combined with VULNOLIGHT red light to the usual care helps improve healing of infected diabetic foot ulcers. Researchers want to see if this combined treatment reduces bacterial load and helps ulcers heal better than usual care alone. The study is sponsored by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

Who may be eligible for this diabetic foot infection clinical trial?

Adults 18 years or older with type 1 or type 2 diabetes and a chronic infected foot ulcer below the ankle may qualify. Participants must have good blood sugar control and be able to take oral medications. Both men and women can join unless pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic foot infection clinical trial?

Study-related care, including treatments and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for any costs related to attending visits.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05613985

Evaluating the Safety and Effectiveness of VULNOFAST Plus and VULNOLIGHT with Usual Care Compared to Usual Care Alone for Treating Infected Diabetic Foot Ulcers

Led by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. · Updated on 2025-08-08

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the healing of chronic diabetic foot ulcers in patients with diabetes using a new treatment system called VULNOFASTplus combined with VULNOLIGHTred light, compared to the usual care alone. This open-label, randomized, multicenter clinical trial aims to determine if adding this system to usual care improves infection control and ulcer healing. The study is sponsored by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

CONDITIONS

Brief Title

PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Able and willing to give voluntary written informed consent before any study procedures
Male or female outpatients or inpatients aged 18 years or older with type 1 or type 2 diabetes
Glycated haemoglobin (HbA1c) level less than or equal to 10% within 3 months before enrolment or at Visit 1
Fasting plasma glucose less than 300 mg/dl
Chronic diabetic foot ulcer below the malleolus with area between 2 and 40 cm2 and maximum diameter up to 10 cm
Ulcer depth grade 2 or higher by PEDIS "Depth/tissue loss" category but not involving bone
Presence of infected foot ulcer grade 2 by PEDIS "Infection" category
Able to take oral medications
Willing and able to comply with study procedures

You will not qualify if you...

Unable to give written informed consent
Pregnant or lactating females
Females of childbearing potential not using adequate contraception
Participation in another clinical trial or investigational product within 30 days before Visit 1
Ankle brachial systolic blood pressure index less than 0.5 in infected limb
Ulcer that probes to bone
Planned surgery during the study period
Peripheral vascular disease requiring revascularization
Transcutaneous oximetry less than 30 mmHg
Use of any antibiotics within 48 hours before Visit 1
Contraindication to punch biopsy
Cannot take amoxicillin and clavulanic acid as prescribed
Cannot be treated with topical iodopovidone antiseptic or iodopovidone gauze due to contraindications

Research Team

Ilaria Corti

Laura Checcaglini

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Evaluating the Safety and Effectiveness of VULNOFAST Plus and VULNOLIGHT with Usual Care Compared to Usual Care Alone for Treating Infected Diabetic Foot Ulcers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria