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出境医 / 临床实验 / Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers
Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers
Study Description
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.
Study Design
| 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 : | October 20, 2020 |
| Estimated Primary Completion Date : | April 15, 2022 |
| Estimated Study Completion Date : | September 20, 2022 |
Arms 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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
Eligibility Criteria
| 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).
Contacts and Locations
Contacts
| Contact: Fredirick L Mashili, MD,PhD. | +255752255949 | fredirick@gmail.com | |
| Contact: Zulfiqar G Abbas, MD. | +255754-693376 | zabbas@cats-net.co.tz |
Locations
| Tanzania | |
| Abbas Medical Center | |
| 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 | |
| Contact: Fredirick Mashili, MD, PhD. +255752255949 fredirick@gmail.com | |
Sponsors and Collaborators
Muhimbili University of Health and Allied Sciences
GlaxoSmithKline
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||||||
| First Posted Date | May 23, 2019 | ||||||||
| Last Update Posted Date | October 8, 2020 | ||||||||
| Estimated Study Start Date | October 20, 2020 | ||||||||
| Estimated Primary Completion Date | April 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
||||||||
| Original Primary Outcome Measures |
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.
|
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| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures |
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers | ||||||||
| Official Title | Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania | ||||||||
| 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. | ||||||||
| 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 | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
Blood specimen for biochemical measurements and wound biopsies for culture and sensitivity testing
|
||||||||
| 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. | ||||||||
| Condition | Diabetic Foot Ulcer | ||||||||
| Intervention | Other: Normal standard care
Both groups will receive standardized treatment and care for diabetic foot ulcers
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 20, 2022 | ||||||||
| Estimated Primary Completion Date | April 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 30 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| Listed Location Countries | Tanzania | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03960255 | ||||||||
| Other Study ID Numbers | DA.282/298/01.C/ | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Fredirick Mashili, Muhimbili University of Health and Allied Sciences | ||||||||
| Study Sponsor | Muhimbili University of Health and Allied Sciences | ||||||||
| Collaborators | GlaxoSmithKline | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Muhimbili University of Health and Allied Sciences | ||||||||
| Verification Date | October 2020 | ||||||||
