Predictors of Foot Amputation in Diabetic Foot Ulcers

NCT05551988 | Completed

• 1 other identifier: BUMHS/IRB/22
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Amputation; Antibiotic Resistant Strain; Diabetic Foot Ulcer

Keywords

antimicrobial resistance; antibiotic resistance; risk factors of amputation; predictors of amputation

Outcome Measures

Primary Outcomes (2)

• 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

• Predictors of amputation in diabetic foot ulcer patient

  Analyze the risk factors of amputation in diabetic foot ulcer patient

  10 months

Secondary Outcomes (1)

• Antibiotic resistance level

  10 months

Study Arms (1)

diabetic foot ulcer patients

Diabetic foot ulcer patients with and without diabetic foot amputation

Other: Retrospective observational study of diabetic foot ulcer

Interventions

Retrospective observational study of diabetic foot ulcer OTHER

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

diabetic foot ulcer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult diabetic foot ulcer patients visiting endocrine department of tertiary care hospitals of Balochsitan, Pakistan with or with out amputation.

You may qualify if:

• All diabetic foot patients (male and female) aged 18 and above;
• Patients visiting Endocrine department of tertiary care hospitals of Balochistan, Pakistan

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bolan Medical Complex Hospital Quetta Pakistan: lead

Study Sites (1)

Bolan Medical Complex Hospital Quetta, Pakistan

Quetta, Balochistan, 87300, Pakistan

Location

Related Publications (8)

• 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, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

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

  PMID: 27585063 BACKGROUND

• 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.

  PMID: 22529027 BACKGROUND

• Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.

  PMID: 16291066 BACKGROUND

• 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.

  PMID: 24035357 BACKGROUND

• Gershater MA, Londahl M, Nyberg P, Larsson J, Thorne 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.

  PMID: 19037626 BACKGROUND

• 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.

  PMID: 29736169 BACKGROUND

• 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.

  PMID: 25946144 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Shairzaman Khan, FCPS

  Bolan Univeristy of Medical and Health Sciences Quetta, Pakistan

  STUDY DIRECTOR

• Taimoor Hussain, MBBS

  Bolan Medical Complex Hospital Quetta Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: June 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

PA (1)