CompletedNot Applicable

This Observational Study Evaluates the Clinical Outcomes of Patients With Diabetes Who Utilize a Specialized Dietary Supplements for Foot Ulcer Healing. The Study Documents the Rate of Complete Wound Closure and the Prevention of Lower Extremity Amputations in a Real-world, At-home Setting.

Algeria35 participantsStarted 2025-07-05

Plain-language summary

This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting.

Who can participate

Age range25 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.

Inclusion Criteria: Diagnosis of Type 1 or Type 2 Diabetes Mellitus. Presence of at least one chronic diabetic foot ulcer (DFU) classified as Wagner Grade 1 to 5. Patients currently facing potential lower extremity amputation as recommended by a surgical consultation. Patients currently adhering to the specific dietary supplements protocol for wound healing. Ability to participate in a 6-week clinical observation period with weekly monitoring. Age 18 years and older. Exclusion Criteria Patients with non-diabetic ulcers (e.g., pressure sores not related to diabetes or purely venous stasis ulcers). Pregnancy or breastfeeding. Exclusion Criteria: Pregnant women

What they're measuring

Rate of Complete Wound Closure.

Timeframe: 06 weeks

Rate of Complete Wound Closure

Timeframe: Baseline and 6 weeks.

Incidence of Lower Extremity Amputation.

Timeframe: Up to 06 weeks

Trial details

NCT IDNCT07442110

SponsorAmar h Zireg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-02

View on ClinicalTrials.gov More Limb Salvage trials