A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers

A Vinayak; Anjali Shah; Mahesh Belhekar; Bhaskar Krishnamurthy; Monty Khajanchi; Ram Prajapati

doi:10.62425/rtpharma.1969566

A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers

Abstract

Objective: Screening in clinical trials ensures participant eligibility, supporting safety and scientific validity. The CONsolidated Standards of Reporting Trials flowchart reports eligibility assessments but often omits detailed exclusion reasons. Understanding screen failures can help refine eligibility criteria, improve recruitment, and guide future trial designs. A pilot study on topical phenytoin for diabetic foot ulcers at our institute had a high screen failure rate. This study aimed to identify the reasons behind those failures. Methods: This retrospective observational study was conducted at a tertiary care hospital. Following ethics approval, demographic and clinical data, including lab values and Ankle-Brachial Pressure Index (ABPI), were extracted from screening records. Screen failure frequencies were analyzed and their causes categorized to identify common patterns. Results: Of 42 participants screened in the original study, 14 (33%) were excluded. The leading reason was elevated glycated haemoglobin (HbA1c) (50%, n=7), followed by high ABPI (29%, n=4) and low protein levels (14%, n=2). Categorization of causes of screen failures showed uncontrolled type-2 diabetes mellitus (44%, n=7) as the primary cause, followed by diabetes-related complications (31%, n=5) and comorbidities (19%, n=3). Conclusion: Elevated HbA1c was the most common reason for screen failure followed by high ABPI, highlighting the challenges of designing strict criteria in diabetic foot ulcer trials. Adjusting HbA1c thresholds while ensuring safety may enhance recruitment without compromising study integrity. Future studies should consider more flexible criteria to improve feasibility and enrollment.

Keywords

Supporting Institution

Seth G.S. Medical College and K.E.M. Hospital, Mumbai

Project Number

EC/OA-132/2024

Ethical Statement

The study was approved by the Institutional Ethics Committee-III of Seth G.S. Medical College and K.E.M. Hospital, Mumbai with the project number EC/OA-132/2024 dated 30 October 2024.

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Details

Primary Language

English

Subjects

Clinical Pharmacology and Therapeutics

Journal Section

Research Article

Authors

A Vinayak
0009-0002-8832-348X
India

Anjali Shah
0009-0008-0634-883X
India

Mahesh Belhekar
0009-0005-5774-0565
India

Bhaskar Krishnamurthy ^*
0000-0003-2381-5352
India

Monty Khajanchi
0000-0002-0898-6391
India

Ram Prajapati
0000-0002-5775-6445
India

Early Pub Date

October 6, 2026

Publication Date

-

Submission Date

June 22, 2026

Acceptance Date

September 1, 2026

Published in Issue

Year 2026 Number: Advanced Online Publication

DOI

https://doi.org/10.62425/rtpharma.1969566

IZ

https://izlik.org/JA94EC47PB

Cite

RIS / Bibtex

APA

Vinayak, A., Shah, A., Belhekar, M., Krishnamurthy, B., Khajanchi, M., & Prajapati, R. (2026). A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers. Recent Trends in Pharmacology, Advanced Online Publication. https://doi.org/10.62425/rtpharma.1969566

AMA

1.Vinayak A, Shah A, Belhekar M, Krishnamurthy B, Khajanchi M, Prajapati R. A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers. Recent Trends in Pharmacology. 2026;(Advanced Online Publication). doi:10.62425/rtpharma.1969566

Chicago

Vinayak, A, Anjali Shah, Mahesh Belhekar, Bhaskar Krishnamurthy, Monty Khajanchi, and Ram Prajapati. 2026. “A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers”. Recent Trends in Pharmacology, no. Advanced Online Publication. https://doi.org/10.62425/rtpharma.1969566.

EndNote

Vinayak A, Shah A, Belhekar M, Krishnamurthy B, Khajanchi M, Prajapati R (October 1, 2026) A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers. Recent Trends in Pharmacology Advanced Online Publication

IEEE

[1]A. Vinayak, A. Shah, M. Belhekar, B. Krishnamurthy, M. Khajanchi, and R. Prajapati, “A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers”, Recent Trends in Pharmacology, no. Advanced Online Publication, Oct. 2026, doi: 10.62425/rtpharma.1969566.

ISNAD

Vinayak, A - Shah, Anjali - Belhekar, Mahesh - Krishnamurthy, Bhaskar - Khajanchi, Monty - Prajapati, Ram. “A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers”. Recent Trends in Pharmacology. Advanced Online Publication (October 1, 2026). https://doi.org/10.62425/rtpharma.1969566.

JAMA

1.Vinayak A, Shah A, Belhekar M, Krishnamurthy B, Khajanchi M, Prajapati R. A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers. Recent Trends in Pharmacology. 2026. doi:10.62425/rtpharma.1969566.

MLA

Vinayak, A, et al. “A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers”. Recent Trends in Pharmacology, no. Advanced Online Publication, Oct. 2026, doi:10.62425/rtpharma.1969566.

Vancouver

1.A Vinayak, Anjali Shah, Mahesh Belhekar, Bhaskar Krishnamurthy, Monty Khajanchi, Ram Prajapati. A Retrospective Observational Study to Evaluate the Causes of Screen Failure in a Pilot Study on Diabetic Foot Ulcers. Recent Trends in Pharmacology. 2026 Oct. 1;(Advanced Online Publication). doi:10.62425/rtpharma.1969566