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

Muhimbili University of Health and Allied Sciences (MUHAS)

Status: Enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Other: Normal standard care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03960255

DA.282/298/01.C/

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

300 participants in 2 patient groups

Normal adiposity group

Description:

Body fat \< 25% and \<32% in men and women respectively, will be categorized as high adiposity. This is according to the The American Council on Exercise criteria.

Treatment:

Other: Normal standard care

High adiposity group

Description:

Body fat ≥ 25% and ≥32% in men and women respectively, will be categorized as high adiposity. This is according to the The American Council on Exercise criteria.

Treatment:

Other: Normal standard care