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

Not Applicable

Terminated

• Conditions: Diabetic Ulcers on Both Feet; Diabetic Foot Ulcer Ischemic; Amputation; Traumatic, Limb; Sexual Dysfunction
• Interventions: Behavioral: Diabetes education

• Registration Number: NCT04078854
• Lead Sponsor: Montefiore Medical Center

Brief 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

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 Timeline

• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-08-31
• Study First Posted: 2019-09-06
• Study Start: 2020-07-08
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foot amputation, sexual health	Diabetes education	Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health
Foot amputation, no sexual health	Diabetes education	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States