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Diabetes education for Diabetic Foot Ulcer

N/A
Waitlist Available
Led By Issam Koleilat, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 1 year, 2 years
Awards & highlights

Study Summary

This trial will compare two types of education given to inpatients with diabetes who have had a minor foot amputation, to see which leads to better HbA1c levels and fewer future amputations.

Eligible Conditions
  • Diabetic Foot Ulcer
  • Amputation
  • Sexual Dysfunction
  • Foot Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 1 year, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin A1c (HbA1c) levels
Secondary outcome measures
Change in LDL Cholesterol levels
Number of Deaths
Number of amputations of lower extremities
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Foot amputation, sexual healthExperimental Treatment1 Intervention
Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health
Group II: Foot amputation, no sexual healthActive Control1 Intervention
Group 2, Control arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations, with no mention about sexual health
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes education
2008
N/A
~110

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,525 Total Patients Enrolled
Issam Koleilat, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
Jeffrey Indes 2020. "The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04078854.
~4 spots leftby Apr 2025
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