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

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04078854
• Other study ID #: 2019-10489
• Status: Terminated
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: March 16, 2022

Study information

• Verified date: September 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Limb
• Diabetic Foot
• Diabetic Foot Ulcer Ischemic
• Diabetic Ulcers on Both Feet
• Foot Ulcer
• Sexual Dysfunction
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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