Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960255
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Fredirick Mashili, Muhimbili University of Health and Allied Sciences

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.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Other: Normal standard care

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Biospecimen Retention:   Samples Without DNA
Blood specimen for biochemical measurements and wound biopsies for culture and sensitivity testing


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960255


Contacts
Layout table for location contacts
Contact: Fredirick L Mashili, MD,PhD. +255752255949 fredirick@gmail.com
Contact: Zulfiqar G Abbas, MD. +255754-693376 zabbas@cats-net.co.tz

Locations
Layout table for location information
Tanzania
Abbas Medical Center Not yet recruiting
Dar es Salam, Tanzania, 21361
Contact: Zulfiqar G Abbas, MD    +255754-693376    zabbas@cats-net.co.tz   
Muhimbili Academic Medical Center
Dar es Salam, Tanzania, 65001
Sponsors and Collaborators
Muhimbili University of Health and Allied Sciences
GlaxoSmithKline

Layout table for additonal information
Responsible Party: Fredirick Mashili, Principal investigator, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT03960255     History of Changes
Other Study ID Numbers: DA.282/298/01.C/
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fredirick Mashili, Muhimbili University of Health and Allied Sciences:
Adiposity
Diabetic foot ulcer
Anti-microbial resistance
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Foot
Foot Ulcer
Obesity
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms