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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.
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol levels | LDL | 3 months, 6 months, 1 year, 2 years |
| Number of Deaths | Mortality | 3 months, 6 months, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
None
Yes all genders are eligible
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| Name | Affiliation | Role |
|---|---|---|
| Issam Koleilat, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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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.
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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.
|
| Number of amputations of lower extremities | Amputation | 3 months, 6 months, 1 year, 2 years |
| Number of re-amputations | higher level or contralateral leg | 3 months, 6 months, 1 year, 2 years |
| Number of patients with mobility problems | Number of blocks patient can walk before claudication | 3 months, 6 months, 1 year, 2 years |
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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