Diabetic Ulcers on Both FeetNCT04078854
The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention
A study testing Diabetes education in people with Diabetic Ulcers on Both Feet and Amputation; Traumatic, Limb, run by Montefiore Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction
- What is being tested?
- Diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c 6.5 and above
- had minor foot amputation this hospitalization
- Age 18 years old and older
- All ethnicities
- Both genders
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)
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
Read the detailed description
This is a single center prospective randomized study evaluating inpatient diabetics after initial minor foot amputations.
- 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)
- Conditions
- Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction, Diabetic Foot Ulcer Ischemic
- Being tested
- Diabetes education
- Keywords
- Diabetic Foot, Sexual Dysfunction, Amputation
- Medical subject headings
- Sexual Dysfunction, Physiological, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes educationBehavioural
Also called Sexual dysfunction in diabetes
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Diabetes education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c (HbA1c) levels
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
Measured: 3 months, 6 months, 1 year, 2 years
Secondary outcomes (5)
Change in LDL Cholesterol levels
LDL
Measured: 3 months, 6 months, 1 year, 2 years
Number of Deaths
Mortality
Measured: 3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities
Amputation
Measured: 3 months, 6 months, 1 year, 2 years
Number of re-amputations
higher level or contralateral leg
Measured: 3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems
Number of blocks patient can walk before claudication
Measured: 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start8 Jul 2020
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Ulcers on Both FeetStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issam Koleilat, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078854
- Sponsor's protocol ID
- 2019-10489
- Other IDs
- 2019
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2019
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention (SAFER GAP)
- ClinicalTrials.gov ID
- NCT04078854
- Acronym / sponsor ID
- 2019-10489
- Conditions
- Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction, Diabetic Foot Ulcer Ischemic
- Keywords
- Diabetic Foot, Sexual Dysfunction, Amputation
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Foot amputation, sexual health | Experimental | Behavioral: Diabetes educationGroup 1, Experimental arm: inpatient diabetics after initial minor foot amputation, who will be shown video on diabetes and foot amputations plus sexual health |
| Foot amputation, no sexual health | Active comparator | Behavioral: Diabetes educationGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HbA1c 6.5 and above
- had minor foot amputation this hospitalization
- Age 18 years old and older
- All ethnicities
- Both genders
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes educationAlso: Sexual dysfunction in diabetesBoth 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. | Behavioural | Foot amputation, no sexual health, Foot amputation, sexual health |
Primary outcome
Change in hemoglobin A1c (HbA1c) levels
Time frame: 3 months, 6 months, 1 year, 2 years
HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin
5 secondary outcomes
Change in LDL Cholesterol levels
Time frame: 3 months, 6 months, 1 year, 2 years
Number of Deaths
Time frame: 3 months, 6 months, 1 year, 2 years
Number of amputations of lower extremities
Time frame: 3 months, 6 months, 1 year, 2 years
Number of re-amputations
Time frame: 3 months, 6 months, 1 year, 2 years
Number of patients with mobility problems
Time frame: 3 months, 6 months, 1 year, 2 years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Koleilat, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes education in people with Diabetic Ulcers on Both Feet and Amputation; Traumatic, Limb, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin A1c (HbA1c) levels (time frame: 3 months, 6 months, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.