Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Proportion (%) of patients with complete wound healing at 24 weeks
研究概览
简要总结
Diabetic foot ulcers (DFUs) and their associated complications like amputations are increasingly becoming a problem in low and middle income (LMI) countries. Obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in LMI setting. It is however not certain whether increased adiposity, may make it difficult for DFUs to heal. Investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of DFUs.
详细描述
A prospective cohort of 300 individuals with type 2 diabetes presenting with diabetic foot ulcers (DFUs) at an outpatient clinic will be recruited. At baseline, participants will be stratified into normal and high adiposity groups as measured by Bioelectrical Impedance Analysis (BIA). Both groups will receive DFU management according to locally appropriate standards of care and followed-up for 24 weeks or until complete wound healing, whichever occurs first. Local microbial characteristics, presence or absence of infection and other clinical parameters will also be assessed, and compared between the two groups. Enrolling 150 participants per group will have a minimum power of 80% to detect a 20% difference in cumulative incidence of complete ulcer healing (at the 5% level of statistical significance) between the normal and high adiposity groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes mellitus (T2DM)
- •Presence of participant's signed informed consent
- •Age 30 years and above at the time the participant is signing the consent
- •Tanzanians of African origin (Black Tanzanians)
- •Presence of diabetic foot ulcer (DFUs) (new or recurrent)
排除标准
- •Known patients with congestive cardiac and/or renal failure.
- •Any patients with absolute or relative contraindication for tissue biopsy (for incident cases)
- •Patients with obvious signs of gangrene
- •DFU patients with non-healing ulcer of more than 52 weeks duration.
- •DFU patients with below normal body mass index BMI (BMI below 18).
结局指标
主要结局
Proportion (%) of patients with complete wound healing at 24 weeks
时间窗: 24 weeks
Complete healing will be defined based on the criteria of the wound healing society, as 100% re-epithelialization of the wound surface (complete wound closure) with a complete absence of drainage.
次要结局
- Proportion of patients with worsening or improving ulcer progression (worsening of improving based on University of Texas ulcer grading system)(24 weeks)
- Proportion of patients who Die(24 weeks)
- Proportion of patients ending up in amputation(24 weeks)
研究者
Fredirick Mashili
Principal investigator
Muhimbili University of Health and Allied Sciences