Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic… (NCT03960255) | Clinical Trial Compass
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 range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion (%) of patients with complete wound healing at 24 weeks
Timeframe: 24 weeks
Trial details
NCT IDNCT03960255
SponsorMuhimbili University of Health and Allied Sciences