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| ID | Type | Description | Link |
|---|---|---|---|
| AZ-DFU-2025-06 | Other Identifier | Amar hocine Zireg |
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| Name | Class |
|---|---|
| Self funded | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amar hocine Zireg | Bordj Bou Arreridj | Wilaya de Bordj Bou Arréridj | 34000 | Algeria |
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| Weekly for up to 6 weeks. |
| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003929 | Diabetic Neuropathies |
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