An observational study in Limb Salvage, Diabetes Complication and Dietary Supplements, sponsored by Amar h Zireg. Completed at 1 site in Algeria. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Amar h Zireg · Observational
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.
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
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 35 is below the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Amar h Zireg is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population consists of 35 adult patients (both male and female) diagnosed with Type 1 or Type 2 Diabetes Mellitus who present with chronic, unhealed diabetic foot ulcers (Wagner Stages 1 to 5). This group includes high-risk individuals who have previously undergone minor amputations (e.g., toe/digit) or were clinically scheduled for lower extremity amputations due to failed standard wound care. The participants are observed in an at-home setting, where they self-administer the specialized dietary supplement protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Patients with Type 1 and 2 diabetes self-administering or prescribed a specific dietary supplements for wound care. Intervention (Observed): Type: Dietary Supplements Name: Diabetic Foot Ulcer Nutritional Protocol
Dietary Supplement: Diabetic foot ulcer treatment by dietary supplements
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
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: 06 weeks
Rate of Complete Wound Closure
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.
Time frame: Baseline and 6 weeks.
Incidence of Lower Extremity Amputation.
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.
Time frame: Up to 06 weeks
Change in Qualitative Tissue Granulation
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.
Time frame: Weekly for up to 6 weeks.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Amar h Zireg