The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)

The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot amputation

Study Overview

• Status: Terminated
• Conditions: Sexual Dysfunction; Amputation; Traumatic, Limb; Diabetic Ulcers on Both Feet; Diabetic Foot Ulcer Ischemic
• Intervention / Treatment: Behavioral: Diabetes education

Detailed Description

This is a single center prospective randomized study evaluating inpatient diabetics after initial minor foot amputations.

b) When a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents and medical students will spend 15-30 minutes with the patient to enroll and give one of the two education video presentations. The video presentations are the narrated versions of the slides attached to the IRB application. We will have both English and Spanish videos available. Because we are using video education, the education provided will be standardized across all patients, and there will be minimal variation in education provided despite using different research associates. The patients will be randomized to one of the two presentations. Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes. Each enrollee will also be asked if they are receiving structured diabetes education at the Montefiore Diabetic Center and will be encouraged to follow up to receive structured education there.

The education presentation will occur after post-operative day 1 after minor foot amputations.

Primary Outcome: HbA1c level Secondary Outcomes: LDL level, Mortality, Re-amputation (higher level or contralateral leg)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HbA1c 6.5 and above
• had minor foot amputation this hospitalization
• Age 18 years old and older
• All ethnicities
• Both genders

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foot amputation, sexual health; Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health	Behavioral: Diabetes education; Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.; Other Names: Sexual dysfunction in diabetes
Active Comparator: Foot amputation, no sexual health; 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	Behavioral: Diabetes education; Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.; Other Names: Sexual dysfunction in diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin A1c (HbA1c) levels	HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin	3 months, 6 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL Cholesterol levels	LDL	3 months, 6 months, 1 year, 2 years
Number of Deaths	Mortality	3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities	Amputation	3 months, 6 months, 1 year, 2 years
Number of re-amputations	higher level or contralateral leg	3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems	Number of blocks patient can walk before claudication	3 months, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Issam Koleilat, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: August 31, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Amputation; Sexual Dysfunction; Diabetic Foot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Wounds and Injuries; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Amputation, Traumatic
• Other Study ID Numbers: 2019-10489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No