Predictors of Foot Amputation in Diabetic Foot Ulcers; A Retrospective Study From Pakistan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Predictors of amputation in diabetic foot ulcer patient
Study Overview
Brief Summary
Diabetes affects 463 million population of the world. Diabetic foot is one of the complications of uncontrolled diabetes which can lead to amputation in 5- 24% of non-healing diabetic foot ulcers. Every 30 seconds a lower extremity is amputated in the world due to diabetes.
This is a retrospective study conducted in Balochistan, Pakistan. In this study investigators explored the risk factor of amputation in diabetic patients. Baseline characteristics, clinical profile, and lab tests were retrieved retrospectively and presented in the forms of tables. Investigators compared the categorical variables in amputees vs non-amputees and analyzed associated risk factors of amputation.
Detailed Description
Proposal
In 2019 around 463 million (9.3%) of the global adult population (20-79 years) were estimated to be living with diabetes. This is a 62% increase from 2009 prevalence data which is projected to increase by another 10.9% (700 million) by 2045. What is surprising and more concerning is that almost half of the affected do not know they have diabetes. Pakistan with 19.6 million diabetics ranks fourth in terms of prevalence.
Uncontrolled diabetes leads to grave complications like diabetic retinopathy, neuropathy, nephropathy, and cardiovascular complications. Diabetic foot is one of the complications that causes significant disability. The global diabetic foot ulcer prevalence was 6.3% - 5.5% in Asia and with 13% in north America (13%). Although, majority (60-80%) of foot ulcers will heal, 5-24% of the remaining active ulcers will in the long run cause limb amputation within 6 to 18 months after the first evaluation. In fact, every 30 seconds in the world, a lower limb is amputated due to diabetes.
Diabetic foot amputations are associated with several risk factors, including peripheral vascular disease (PVD), neuropathy, longer diabetes duration, nephropathy, older age, poor glycemic control, comorbidities like coronary artery disease (CAD), preventive foot care, socioeconomic status, male gender, smoking, hypertension, and hyperlipidemia. Diabetic wound care management and foot care awareness and habits also play a definitive role in the outcome.
In this study investigators explored the baseline demographic, clinical, and lab investigations profile of diabetic foot patients visiting tertiary care hospitals of Baluchistan, Pakistan. Investigators also explored the associated risk factors of amputations in patients. The regional epidemiological knowledge and identifying the risk factors will guide physicians to improve patients' quality of life and reduce the economic burden for both the patient and the health care system.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All diabetic foot patients (male and female) aged 18 and above;
- •Patients visiting Endocrine department of tertiary care hospitals of Balochistan, Pakistan
Exclusion Criteria
- •Patients who have received prior treatment with antibiotics in the last one month
- •Patient with end stage renal disease requiring regular hemodialysis
- •Those with a history of previous vascular surgery of involved limb
- •Those who received hyperbaric oxygen therapy
- •Those with unrelated skin disease around the involved foot will be excluded.
Outcomes
Primary Outcomes
Predictors of amputation in diabetic foot ulcer patient
Time Frame: 10 months
Analyze the risk factors of amputation in diabetic foot ulcer patient
Baseline characteristics of amputees vs non amputees
Time Frame: 10 months
Explore the baseline demographic, clinical, and lab investigations profile of diabetic foot patients visiting tertiary care hospitals of Baluchistan, Pakistan
Secondary Outcomes
- Antibiotic resistance level(10 months)
Investigators
Taimoor Hussain
Medical Officer
Bolan Medical Complex Hospital Quetta Pakistan