Clinical trial NCT04078854: 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
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Ulcers on Both Feet
Amputation; Traumatic, Limb
Sexual Dysfunction
Diabetic Foot Ulcer Ischemic
Keywords: Diabetic Foot
Sexual Dysfunction
Amputation
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Change in hemoglobin A1c (HbA1c) levels
timeFrame: 3 months, 6 months, 1 year, 2 years
Secondary outcomes:
measure: Change in LDL Cholesterol levels
timeFrame: 3 months, 6 months, 1 year, 2 years
measure: Number of Deaths
timeFrame: 3 months, 6 months, 1 year, 2 years
measure: Number of amputations of lower extremities
timeFrame: 3 months, 6 months, 1 year, 2 years
measure: Number of re-amputations
timeFrame: 3 months, 6 months, 1 year, 2 years
measure: Number of patients with mobility problems
timeFrame: 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Issam Koleilat, MD
role: PRINCIPAL_INVESTIGATOR
References: