UnknownNot Applicable

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

Tanzania300 participantsStarted 2021-02-20

Plain-language 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.

Who can participate

Age range30 Years

SexALL

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Inclusion Criteria: * 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) Exclusion Criteria: * 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).

What they're measuring

Proportion (%) of patients with complete wound healing at 24 weeks

Timeframe: 24 weeks

Trial details

NCT IDNCT03960255

SponsorMuhimbili University of Health and Allied Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-15

Contact for this trial

Fredirick L Mashili, MD,PhD.

+255752255949 fredirick@gmail.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials