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

December 28, 2022 updated by: Fredirick Mashili, Muhimbili University of Health and Allied Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tanzania
      • Dar es Salam, Tanzania, 21361
        • Not yet recruiting
        • Abbas Medical Center
        • Contact:
      • Dar es Salam, Tanzania, 65001
        • Not yet recruiting
        • Muhimbili Academic Medical Center
        • Contact:
      • Dar es Salam, Tanzania, 65001
        • Recruiting
        • Temeke regional hospital
        • Contact:
        • Contact:
          • Boniface Mphumuhila, MD
          • Phone Number: +255758036988
    • Unguja
      • Zanzibar, Unguja, Tanzania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal adiposity group
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.
Other: Normal standard care
Both groups will receive standardized treatment and care for diabetic foot ulcers
High adiposity group
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.
Other: Normal standard care
Both groups will receive standardized treatment and care for diabetic foot ulcers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion (%) of patients with complete wound healing at 24 weeks
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with worsening or improving ulcer progression (worsening of improving based on University of Texas ulcer grading system)
Time Frame: 24 weeks
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
Proportion of patients ending up in amputation
Time Frame: 24 weeks
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
Proportion of patients who Die
Time Frame: 24 weeks
Proportion (%) of patients who die among those enrolled into the study within the study time frame
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhimbili University of Health and Allied Sciences

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Anticipated)

April 15, 2023

Study Completion (Anticipated)

May 20, 2023

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA.282/298/01.C/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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