Clinical trial NCT03960255: Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers
Official title: Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcer
Keywords: Adiposity
Diabetic foot ulcer
Anti-microbial resistance
Lead sponsor: Muhimbili University of Health and Allied Sciences
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2019-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants (males and females) will be newly reporting and known type 2 diabetes mellitus (T2DM) patients with diabetic foot ulcer (DFU) of any class, stage and grade (based on the university of Texas ulcer staging system). Any prior treatment and important information related to the ulcers and patients will be recorded using a pre-tested questionnaire. DFU will be defined as a full-thickness wound, through the dermis, below the ankle in an individual with T2DM. Duration of ulcers will be measured and reported in weeks. To recruit appropriate participants, a careful examination will be done with qualified and trained personnel. Prior to commencement of the study appropriate manuals and standard operating procedures will be prepared and used throughout the study period.

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion (%) of patients with complete wound healing at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of patients with worsening or improving ulcer progression (worsening of improving based on University of Texas ulcer grading system)
timeFrame: 24 weeks
measure: Proportion of patients ending up in amputation
timeFrame: 24 weeks
measure: Proportion of patients who Die
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Zanzibar
country: Tanzania
facility: Mnazi Mmoja Hospital
state: Unguja
city: Dar es Salam
country: Tanzania
facility: Abbas Medical Center
city: Dar es Salam
country: Tanzania
facility: Muhimbili Academic Medical Center
city: Dar es Salam
country: Tanzania
facility: Temeke regional hospital
Study officials:
References:
citation: Mashili F, Joachim A, Aboud S, Mchembe M, Chiwanga F, Addo J, Kendall L, Ako A, Abbas Z. Prospective exploration of the effect of adiposity and associated microbial factors on healing and progression of diabetic foot ulcers in Tanzania: study protocol of a longitudinal cohort study. BMJ Open. 2019 Dec 16;9(12):e031896. doi: 10.1136/bmjopen-2019-031896.