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

Primary Purpose

Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes education
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Ulcers on Both Feet focused on measuring Diabetic Foot, Sexual Dysfunction, Amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Foot amputation, sexual health

Foot amputation, no sexual health

Arm Description

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 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

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c (HbA1c) levels
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin

Secondary Outcome Measures

Change in LDL Cholesterol levels
LDL
Number of Deaths
Mortality
Number of amputations of lower extremities
Amputation
Number of re-amputations
higher level or contralateral leg
Number of patients with mobility problems
Number of blocks patient can walk before claudication

Full Information

First Posted
August 31, 2019
Last Updated
September 7, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04078854
Brief Title
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
Official Title
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
IRB approval expired on 3/16/2022. Study would need to be reapproved by the IRB with a new submission given the duration of expiration.
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction, Diabetic Foot Ulcer Ischemic
Keywords
Diabetic Foot, Sexual Dysfunction, Amputation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Participants do not know that there are two types of presentations. When a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents or medical students will spend 15 to 30 minutes with the patient to enroll and give one of the two education video presentations. The patients will be randomized to one of the two presentations.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foot amputation, sexual health
Arm Type
Experimental
Arm Description
Group 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health
Arm Title
Foot amputation, no sexual health
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Diabetes education
Other Intervention Name(s)
Sexual dysfunction in diabetes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c (HbA1c) levels
Description
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
Time Frame
3 months, 6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Change in LDL Cholesterol levels
Description
LDL
Time Frame
3 months, 6 months, 1 year, 2 years
Title
Number of Deaths
Description
Mortality
Time Frame
3 months, 6 months, 1 year, 2 years
Title
Number of amputations of lower extremities
Description
Amputation
Time Frame
3 months, 6 months, 1 year, 2 years
Title
Number of re-amputations
Description
higher level or contralateral leg
Time Frame
3 months, 6 months, 1 year, 2 years
Title
Number of patients with mobility problems
Description
Number of blocks patient can walk before claudication
Time Frame
3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Yes all genders are eligible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Issam Koleilat, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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