Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal standard care | Other | Both groups will receive standardized treatment and care for diabetic foot ulcers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredirick L Mashili, MD,PhD. | Contact | +255752255949 | fredirick@gmail.com | |
| Zulfiqar G Abbas, MD. | Contact | +255754-693376 | zabbas@cats-net.co.tz |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mnazi Mmoja Hospital | Recruiting | Zanzibar | Unguja | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31848165 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood specimen for biochemical measurements and wound biopsies for culture and sensitivity testing
| 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. | 24 weeks |
| Proportion of patients who Die | Proportion (%) of patients who die among those enrolled into the study within the study time frame | 24 weeks |
| Abbas Medical Center | Not yet recruiting | Dar es Salaam | 21361 | Tanzania |
|
| Muhimbili Academic Medical Center | Not yet recruiting | Dar es Salaam | 65001 | Tanzania |
|
| Temeke regional hospital | Recruiting | Dar es Salaam | 65001 | Tanzania |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |