NCT03960255

Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Muhimbili University of Health and Allied Sciences · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	Normal standard care	Both groups will receive standardized treatment and care for diabetic foot ulcers

Timeline

• Start date: 2021-02-20
• Primary completion: 2023-04-15
• Completion: 2023-05-20
• First posted: 2019-05-23
• Last updated: 2022-12-29

Locations

4 sites across 1 country: Tanzania