An interventional study of Diabetes education in Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb and Sexual Dysfunction, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Prevention
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
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)
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's enrollment of 21 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Change in hemoglobin A1c (HbA1c) levels
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
Time frame: 3 months, 6 months, 1 year, 2 years
Change in LDL Cholesterol levels
LDL
Time frame: 3 months, 6 months, 1 year, 2 years
Number of Deaths
Mortality
Time frame: 3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities
Amputation
Time frame: 3 months, 6 months, 1 year, 2 years
Number of re-amputations
higher level or contralateral leg
Time frame: 3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems
Number of blocks patient can walk before claudication
Time frame: 3 months, 6 months, 1 year, 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Mar 2022, 20 months.
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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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