NCT04078854

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

August 31, 2019

Last Update Submit

September 7, 2023

Conditions

Diabetic Ulcers on Both FeetAmputation; Traumatic, LimbSexual DysfunctionDiabetic Foot Ulcer Ischemic

Keywords

Diabetic FootSexual DysfunctionAmputation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in LDL Cholesterol levels

    3 months, 6 months, 1 year, 2 years

  • Number of Deaths

    3 months, 6 months, 1 year, 2 years

  • Number of amputations of lower extremities

    3 months, 6 months, 1 year, 2 years

  • Number of re-amputations

    3 months, 6 months, 1 year, 2 years

  • Number of patients with mobility problems

    3 months, 6 months, 1 year, 2 years

Study Arms (2)

Foot amputation, sexual health

EXPERIMENTAL

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

Foot amputation, no sexual health

ACTIVE COMPARATOR

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

Interventions

Diabetes educationBEHAVIORAL

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.

Also known as: Sexual dysfunction in diabetes
Foot amputation, no sexual healthFoot amputation, sexual health

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYes all genders are eligible
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalDiabetic Foot

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Issam Koleilat, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 6, 2019

Study Start

July 8, 2020

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)