Diabetic Foot UlcerNCT03960255
Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer, run by Muhimbili University of Health and Allied Sciences at 4 sites in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 300 participants
- Where
- 4 sitesTanzania
- Study dates
- 20 Feb 2021to 20 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Tanzania4 sites, 4 recruiting
- Not yet recruiting
Abbas Medical Center
Dar es Salaam, 21361
Zulfiqar G Abbas, MD, +255754-693376, zabbas@cats-net.co.tz
- Not yet recruiting
Muhimbili Academic Medical Center
Dar es Salaam, 65001
Fredirick Mashili, MD, PhD., +255752255949, fredirick@gmail.com
- Recruiting
Temeke regional hospital
Dar es Salaam, 65001
fredirick mashili, MD, PhD, +255752255949, fredirick@gmail.com
Boniface Mphumuhila, MD, +255758036988
- Recruiting
Mnazi Mmoja Hospital
Zanzibar, Unguja
Ame Masemo, MD, amemasemo@gmail.com
Ashabilan Abdikarim, MD, Msc, +255744043875, ashbilan13@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Normal standard care
- Keywords
- Adiposity, Diabetic foot ulcer, Anti-microbial resistance
- Medical subject headings
- Diabetic Foot, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal standard careOther
Both groups will receive standardized treatment and care for diabetic foot ulcers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Normal standard care | |
| 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. Receives: Other: Normal standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Proportion of patients who Die
Proportion (%) of patients who die among those enrolled into the study within the study time frame
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start20 Feb 2021
- Primary completion15 Apr 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Fredirick Mashili, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960255
- Sponsor's protocol ID
- DA.282/298/01.C/
- Status last verified
- Dec 2022
- First submitted
- 20 May 2019
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31848165
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania
- ClinicalTrials.gov ID
- NCT03960255
- Acronym / sponsor ID
- DA.282/298/01.C/
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Adiposity, Diabetic foot ulcer, Anti-microbial resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal adiposity group | – | Other: Normal standard careBody 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. |
| High adiposity group | – | Other: Normal standard careBody 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal standard careBoth groups will receive standardized treatment and care for diabetic foot ulcers | Other | High adiposity group, Normal adiposity group |
Primary outcome
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.
3 secondary outcomes
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 ending up in amputation
Time frame: 24 weeks
Proportion of patients who Die
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 31848165Mashili 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Muhimbili University of Health and Allied Sciences at 4 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredirick L Mashili, MD,PhD. (+255752255949, fredirick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of patients with complete wound healing at 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.