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

NCT ID: NCT03960255

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-20

Study Completion Date

2023-05-20

Brief Summary

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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

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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.

Conditions

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Diabetic Foot Ulcer

Keywords

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Adiposity Diabetic foot ulcer Anti-microbial resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Normal standard care

Intervention Type OTHER

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.

Normal standard care

Intervention Type OTHER

Both groups will receive standardized treatment and care for diabetic foot ulcers

Interventions

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Normal standard care

Both groups will receive standardized treatment and care for diabetic foot ulcers

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fredirick Mashili

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mnazi Mmoja Hospital

Zanzibar, Unguja, Tanzania

Site Status RECRUITING

Abbas Medical Center

Dar es Salaam, , Tanzania

Site Status NOT_YET_RECRUITING

Muhimbili Academic Medical Center

Dar es Salaam, , Tanzania

Site Status NOT_YET_RECRUITING

Temeke regional hospital

Dar es Salaam, , Tanzania

Site Status RECRUITING

Countries

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Tanzania

Central Contacts

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Fredirick L Mashili, MD,PhD.

Role: CONTACT

Phone: +255752255949

Email: [email protected]

Zulfiqar G Abbas, MD.

Role: CONTACT

Phone: +255754-693376

Email: [email protected]

Facility Contacts

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Ame Masemo, MD

Role: primary

Ashabilan Abdikarim, MD, Msc

Role: backup

Zulfiqar G Abbas, MD

Role: primary

Fredirick Mashili, MD, PhD.

Role: primary

fredirick mashili, MD, PhD

Role: primary

Boniface Mphumuhila, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 31848165 (View on PubMed)

Other Identifiers

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DA.282/298/01.C/

Identifier Type: -

Identifier Source: org_study_id