Predictors of Foot Amputation in Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

Predictors of Foot Amputation in Diabetic Foot Ulcers; A Retrospective Study From Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551988
• Other study ID #: BUMHS/IRB/22
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Bolan Medical Complex Hospital Quetta Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Rationale of the study:

Antimicrobial surveillance studies of diabetic foot are the need of time to detect any variations in regional microbiological profile and rise in antimicrobial resistance, before it turns into a major public health nightmare. Addressing the risk factors of amputation in diabetic foot ulcer patients can avoid this dreadful complication. In this study investigators have attempted to address this void in regional data of diabetic foot. The results of this study will also guide physicians regarding appropriate choice of antibiotics, discourage indiscriminate abuse of antibiotics both by physicians and public, encourage practice of culture studies based treatment.

Operational definitions:

Diabetes Mellitus: Diagnosed at an HbA1C of greater than or equal to 6.5%; or a fasting blood glucose of more 126 mg/dl or higher Diabetic foot: Defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes.

Hypertension: Previous medication of anti-hypertensive drug or a BP ≥ 140/90 mmHg).

Antibiotic resistance happens when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow.

Antibiotic resistance: When germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow.

Multidrug resistance (MDR): Defined as acquired non-susceptibility to at least one agent in three or more antimicrobial categories, Extremely drug resistance (XDR): Defined as non-susceptibility to at least one agent in all but two or fewer antimicrobial categories (i.e. bacterial isolates remain susceptible to only one or two categories) Pan Drug resistance (PDR): Defined as non-susceptibility to all agents in all antimicrobial categories.

Duration and size of ulcer: Calculated by multiplying longest and widest diameters and expressed in centimeter square. Ulcers were graded using Wagner classification system, grade I (superficial ulcer or ulcer of subcutaneous tissue), grade II (ulcers extended into tendon, bone, or capsule), grade III (deep ulcer with osteomyelitis, or abscess), and grade IV (gangrene of toes). Subjects with grade 0 (uninfected lesions/ intact skin/ healed ulcers) were debarred from the study.

Amputation: Defined as the complete loss in the transverse anatomical plane of any part of the lower limb.

Diagnosis of infection involving bone: Done by either using a sterile probe in exposed bone or evidence obtained from plain radiographs.

Data collection procedure: Baseline characteristics of patients such as age, gender, residence district, rural or urban, education, income, HbA1c level, presence or absence of; neuropathy, peripheral arterial disease, amputation, grade and location of ulcer, and comorbidities will be retrieved from records and patient files. Incase of missing data patients shall be contacted for any previous records as needed.

Statistical analysis:

Quantitative variables represented as means ± standard deviation and categorical data as a percentage (%). SPSS and Microsoft Excel will be used to analyze the data . Chi square will be used to analyze for any difference between amputees and non amputees. Univariate logistic regression analysis will be applied to determine the odds ratio of variables as risk factors in amputees vs non amputees. Significant variable in univariate analysis will be entered in to multivariate logistic regression analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Antibiotic Resistant Strain
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• Retrospective observational study of diabetic foot ulcer
This is a retrospective observational study of antibiotic resistance and risk factors of amputation in diabetic foot ulcer patients

Locations

Country	Name	City	State
Pakistan	Bolan Medical Complex Hospital Quetta, Pakistan	Quetta	Balochistan

Sponsors (1)

Lead Sponsor	Collaborator
Bolan Medical Complex Hospital Quetta Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Al-Rubeaan K, Al Derwish M, Ouizi S, Youssef AM, Subhani SN, Ibrahim HM, Alamri BN. Diabetic foot complications and their risk factors from a large retrospective cohort study. PLoS One. 2015 May 6;10(5):e0124446. doi: 10.1371/journal.pone.0124446. eCollection 2015. — View Citation

Alexiadou K, Doupis J. Management of diabetic foot ulcers. Diabetes Ther. 2012 Nov;3(1):4. doi: 10.1007/s13300-012-0004-9. Epub 2012 Apr 20. — View Citation

Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. Review. — View Citation

Gershater MA, Löndahl M, Nyberg P, Larsson J, Thörne J, Eneroth M, Apelqvist J. Complexity of factors related to outcome of neuropathic and neuroischaemic/ischaemic diabetic foot ulcers: a cohort study. Diabetologia. 2009 Mar;52(3):398-407. doi: 10.1007/s00125-008-1226-2. Epub 2008 Nov 27. — View Citation

McEwen LN, Ylitalo KR, Herman WH, Wrobel JS. Prevalence and risk factors for diabetes-related foot complications in Translating Research Into Action for Diabetes (TRIAD). J Diabetes Complications. 2013 Nov-Dec;27(6):588-92. doi: 10.1016/j.jdiacomp.2013.08.003. Epub 2013 Sep 10. — View Citation

Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9(th) edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10. — View Citation

Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659. eCollection 2018. — View Citation

Zhang P, Lu J, Jing Y, Tang S, Zhu D, Bi Y. Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis (†). Ann Med. 2017 Mar;49(2):106-116. doi: 10.1080/07853890.2016.1231932. Epub 2016 Nov 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristics of amputees vs non amputees	Explore the baseline demographic, clinical, and lab investigations profile of diabetic foot patients visiting tertiary care hospitals of Baluchistan, Pakistan	10 months
Primary	Predictors of amputation in diabetic foot ulcer patient	Analyze the risk factors of amputation in diabetic foot ulcer patient	10 months
Secondary	Antibiotic resistance level	Explore the resistance level to most common antibiotics in diabetic foot ulcer patients	10 months