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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03960255
• Other study ID #: DA.282/298/01.C/
• Status: Recruiting
• Start date: February 20, 2021
• Est. completion date: May 20, 2023

Study information

• Verified date: December 2022
• Source: Muhimbili University of Health and Allied Sciences
• Contact: Fredirick L Mashili, MD,PhD.
• Phone: +255752255949
• Email: fredirick[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 20, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Obesity
• Ulcer

Intervention

Other:
• Normal standard care
Both groups will receive standardized treatment and care for diabetic foot ulcers

Locations

Country	Name	City	State
Tanzania	Abbas Medical Center	Dar es Salam
Tanzania	Muhimbili Academic Medical Center	Dar es Salam
Tanzania	Temeke regional hospital	Dar es Salam
Tanzania	Mnazi Mmoja Hospital	Zanzibar	Unguja

Sponsors (2)

Lead Sponsor	Collaborator
Muhimbili University of Health and Allied Sciences	GlaxoSmithKline

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion (%) of patients with complete wound healing at 24 weeks	Complete healing will be defined based on the criteria of the wound healing society, as 100% re-epithelialization of the wound surface (complete wound closure) with a complete absence of drainage.	24 weeks
Secondary	Proportion of patients with worsening or improving ulcer progression (worsening of improving based on University of Texas ulcer grading system)	Proportion (%) of patients with unfavorable progression (worsening) of an ulcer to a more advanced stage/grade or favorable progression (improving) of an ulcer to an earlier stage/grade, among those enrolled into the study within the study time frame. The grades will be evaluated using the University of Texas ulcer grading system.	24 weeks
Secondary	Proportion of patients ending up in amputation	Proportion (%) of patients getting amputations of a toe or foot on the same side as an index ulcer, among those enrolled into the study within the study time frame.	24 weeks
Secondary	Proportion of patients who Die	Proportion (%) of patients who die among those enrolled into the study within the study time frame	24 weeks