At Home Setting, Diabetes Complication, Diabetes Mellitus, Type 1, Type 2, Diabetic Foot Ulcer, Dietary Supplements, Healed Ulcer, Limb Salvage, Wound Closure, Wound Healing
Conditions
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)
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTDiabetic 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
Sponsors
Self funded
Amar h Zireg
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Complete Wound Closure. | 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. |
| Rate of Complete Wound Closure | 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. |
| Incidence of Lower Extremity Amputation. | 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. |
Countries
Algeria
Outcome results
None listed