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NCT Number: NCT07442110

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.

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.

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Key information

About this study

Context: Observation of patients with chronic diabetes mellitus and foot ulcers (Wagner stages 1-5).

Observation: Data collection on the administration of daily nutritional supplements.

Assessment: Weekly monitoring of tissue viability ( granulation tissue growth), reduction in inflammation, and drainage.

Observed Outcomes: Documentation of complete healing rates and limb salvage in high-risk cases where amputation was previously indicated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetic foot ulcer treatment by dietary supplements

Dietary Supplement

Intervention Type: Dietary Supplement Intervention Name: Diabetic Foot Ulcer Nutritional Protocol

Description:

A specific regimen of daily dietary supplements designed to support metabolic health and accelerated tissue repair in diabetic patients.

The protocol involves the administration of targeted nutrients known to enhance collagen synthesis, reduce systemic inflammation.Participants consume the supplements orally on a daily basis over a 6-week period.

The observation focuses on the supplement's ability to facilitate complete wound closure (epithelialization) and salvage limbs in patients previously scheduled for amputation.

Study Status: Completed (s

Primary outcomes

  1. Rate of Complete Wound Closure.

    Time frame: 06 weeks

    Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing.

  2. Rate of Complete Wound Closure

    Time frame: Baseline and 6 weeks.

    Outcome Measure Title: Rate of Complete Wound Closure Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing.

    Time Frame: 6 weeks. Outcome Measure Title: Incidence of Lower Extremity Amputation Measure Description: Number of participants requiring minor (toe/transmetatarsal) or major (above/below-knee) amputations during the observation period.

    Time Frame: Up to 6 weeks. Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure.

    Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.

  3. Incidence of Lower Extremity Amputation.

    Time frame: Up to 06 weeks

    Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure.

    Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.

Other outcomes

  1. Change in Qualitative Tissue Granulation

    Time frame: Weekly for up to 6 weeks.

    Outcome Measure Title: Change in Qualitative Tissue Granulation Measure Description: Clinical observation of the transition in tissue type (from necrotic or stagnant to healthy granulation tissue), assessed via weekly clinical evaluation and standardized photographic evidence.

    This observational study monitors a cohort of 35 participants with Type 1 or Type 2 Diabetes Mellitus presenting with chronic Wagner Stage 1 to 5 foot ulcers. The study observes the clinical progression of patients who self-administer a specialized dietary supplement protocol. Primary data points include the variation in wound surface area and the clinical incidence of lower extremity amputations within a 6-week observation window.

Sponsors and collaborators

Lead sponsor

Amar h Zireg

Other

Collaborators

  • Self funded

Registry information

Official study title

Observational Study of a Specialized Dietary Supplements on the Healing of Diabetic Foot Ulcers and Prevention of Amputations

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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