Observational Study of a Specialized Dietary Supplements on the Healing of Diabetic Foot Ulcers and Prevention of Amputations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rate of Complete Wound Closure.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Diabetic foot ulcer treatment by dietary supplements (Dietary Supplement)
结局指标
主要结局
Rate of Complete Wound Closure.
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Amar h Zireg
Amar hocine Zireg
Amar Zireg