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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL143178-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.
This is a clustered trial where patients identified as having lower extremity ulcers with peripheral artery disease and diabetes are given the option to be seen by specialty care providers through telemedicine vs. normal standard in person referral. The study is being conducted in rural areas where there are no in person vascular surgery providers. The aim of the study is to determine if patient activation affects likelihood to use telemedicine and if use of telemedicine can expedite speciality care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Telemedicine specialty consultation for patients |
|
| Standard Care | No Intervention | Standard in person referral to a specialist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine specialty consultation | Other | Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine |
| Measure | Description | Time Frame |
|---|---|---|
| Specialty Consultation | The time from the date the wound is identified to the date of specialist consultation, in days. | up to 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Revascularization | The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days. | up to 365 days |
| Wound Healing | The time from when the wound is identified until the wound heals, in days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Misty D Humphries | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misty D. Humphries | Sacramento | California | 95811 | United States |
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All subjected had to have a wound on the foot.
Subjects were recruited from two clinical sites where wound care was provided. One site had access to revascularization services and the other did not.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine | Participants received specialty wound care consultations through telemedicine. |
| FG001 | Standard Care | Participants received usual wound care at their clinic without telemedicine consultation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 |
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Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.
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| up to 365 days |
| Amputation | Major (above the ankle) or minor (toe/TMA) amputation of the index leg. | up to 365 days |
| COMPLETED |
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| NOT COMPLETED |
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Baseline demographic and clinical characteristics were collected for participants in both the Telemedicine and Standard Care arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine | Telemedicine specialty consultation for patients These subjects were all >18 years old, of all races specifically with a focus on the native American population is the area of one clinic. |
| BG001 | Standard Care | Patent who received wound care without telemedicine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Specialty Consultation | The time from the date the wound is identified to the date of specialist consultation, in days. | Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group. | Posted | Median | Inter-Quartile Range | days | up to 365 days |
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| ||||||||||||||||||||||||||||
| Secondary | Revascularization | The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days. | Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group. | Posted | Median | Inter-Quartile Range | days | up to 365 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Wound Healing | The time from when the wound is identified until the wound heals, in days. | Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group. | Posted | Median | Inter-Quartile Range | days | up to 365 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Amputation | Major (above the ankle) or minor (toe/TMA) amputation of the index leg. | Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group. | Posted | Count of Participants | Participants | up to 365 days |
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From enrollment until completion of follow-up at 6 months.
Death and lost to follow up before healing was considered an adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Telemedicine specialty consultation for patients These subjects were all >18 years old, of all races specifically with a focus on the native American population is the area of one clinic. | 3 | 113 | 0 | 113 | 0 | 113 |
| EG001 | Standard Care | Subjects who had wound care without a telemedicine consultation | 0 | 0 | 0 | 0 | 0 | 0 |
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A significant limitation was the absence of a comparator group for subjects at the most remote telemedicine clinic. However, we were able to enroll subjects and provide them with improved care in the intervention group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Misty Humphries | UNIVERSITY OF CALIFORNIA DAVIS | 9167342028 | mdhumphries@health.ucdavis.edu |
| Jul 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003925 | Diabetic Angiopathies |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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