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.

NCT07442110 | Completed

• 2 other identifiers: ZiregAmarAZ-DFU-2025-06
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Limb Salvage; Diabetes Complication; Dietary Supplements; Healed Ulcer; Wound Closure; At Home Setting; Diabetes Mellitus, Type 1, Type 2; Wound Healing; Diabetic Foot Ulcer

Keywords

Diabetes; limb-salvage; Diabetic foot ulcer; wound closure; complete wound closure; dietary supplements; Type1&2 Diabetes; Complete Wound Closure (CWC); Metabolic Restoration; Wagner Grade 5; Surgical Avoidance; Amputation-Free Survival (AFS)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 06 weeks

Other Outcomes (1)

• Change in Qualitative Tissue Granulation

  Weekly for up to 6 weeks.

Study Arms (1)

Nutritional Supplements

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

Interventions

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

Nutritional Supplements

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or breastfeeding.
• Pregnant women

Sponsors & Collaborators

• Amar h Zireg: lead
• Self funded: collaborator

Study Sites (1)

Amar hocine Zireg

Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, 34000, Algeria

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Amar hocine Zireg

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 2, 2026
• Study Start: July 5, 2025
• Primary Completion: September 2, 2025
• Study Completion: September 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

AL (1)