Studies
| Study First Submitted Date | 2021-10-22 |
| Study First Posted Date | 2021-10-26 |
| Last Update Posted Date | 2023-06-05 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | September 2, 2025 |
| Verification Month Year | June 2023 |
| Verification Date | 2023-06-30 |
| Last Update Posted Date | 2023-06-05 |
Facilities
| Sequence: | 199844043 |
| Name | Edward Hines Jr. VA Hospital, Hines, IL |
| City | Hines |
| State | Illinois |
| Zip | 60141-3030 |
| Country | United States |
Facility Contacts
| Sequence: | 28079985 |
| Facility Id | 199844043 |
| Contact Type | primary |
| Name | Muturi G Muriuki, PhD |
| Muturi.Muriuki@va.gov | |
| Phone | 708-202-5788 |
Facility Investigators
| Sequence: | 18314015 |
| Facility Id | 199844043 |
| Role | Principal Investigator |
| Name | Muturi G. Muriuki, PhD |
Conditions
| Sequence: | 52116532 |
| Name | Diabetic Foot Ulcer |
| Downcase Name | diabetic foot ulcer |
Id Information
| Sequence: | 40116510 |
| Id Source | org_study_id |
| Id Value | A3781-R |
Countries
| Sequence: | 42520355 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55534428 | Sequence: | 55534429 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Treatment group | Title | Control group |
| Description | Patients will be given additional counseling | Description | Patients will be given standard of care. |
Interventions
| Sequence: | 52431477 | Sequence: | 52431478 |
| Intervention Type | Device | Intervention Type | Other |
| Name | Removable cam walker boot | Name | Counseling |
| Description | Standard of care device given to diabetic foot ulcer patients. | Description | Additional education, counseling and encouragement of use of the orthosis beyond the current standard of care. |
Design Outcomes
| Sequence: | 177186902 | Sequence: | 177186903 | Sequence: | 177186904 | Sequence: | 177186905 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Orthosis wear-time | Measure | Foot ulcer size | Measure | Foot ulcer healing status | Measure | Number of foot ulcers |
| Time Frame | At each clinic visit through study completion, an average of 8 months | Time Frame | At each clinic visit through study completion, an average of 8 months | Time Frame | At each clinic visit through study completion, an average of 8 months | Time Frame | At each clinic visit through study completion, an average of 8 months |
| Description | The total time that the orthosis has been worn between clinic visits. | Description | Size of the diabetic foot ulcer. | Description | Status of the diabetic foot ulcer. | Description | The number of diabetic foot ulcers. |
Browse Conditions
| Sequence: | 193274314 | Sequence: | 193274315 | Sequence: | 193274316 | Sequence: | 193274317 | Sequence: | 193274318 | Sequence: | 193274319 | Sequence: | 193274320 | Sequence: | 193274321 | Sequence: | 193274322 | Sequence: | 193274323 | Sequence: | 193274324 | Sequence: | 193274325 | Sequence: | 193274326 | Sequence: | 193274327 | Sequence: | 193274328 |
| Mesh Term | Diabetic Foot | Mesh Term | Foot Ulcer | Mesh Term | Ulcer | Mesh Term | Pathologic Processes | Mesh Term | Diabetic Angiopathies | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Leg Ulcer | Mesh Term | Skin Ulcer | Mesh Term | Skin Diseases | Mesh Term | Diabetes Complications | Mesh Term | Diabetes Mellitus | Mesh Term | Endocrine System Diseases | Mesh Term | Diabetic Neuropathies | Mesh Term | Foot Diseases |
| Downcase Mesh Term | diabetic foot | Downcase Mesh Term | foot ulcer | Downcase Mesh Term | ulcer | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | diabetic angiopathies | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | leg ulcer | Downcase Mesh Term | skin ulcer | Downcase Mesh Term | skin diseases | Downcase Mesh Term | diabetes complications | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | diabetic neuropathies | Downcase Mesh Term | foot diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48269688 |
| Agency Class | FED |
| Lead Or Collaborator | lead |
| Name | VA Office of Research and Development |
Overall Officials
| Sequence: | 29254521 |
| Role | Principal Investigator |
| Name | Muturi G. Muriuki, PhD |
| Affiliation | Edward Hines Jr. VA Hospital, Hines, IL |
Central Contacts
| Sequence: | 11996751 | Sequence: | 11996752 |
| Contact Type | primary | Contact Type | backup |
| Name | Muturi G Muriuki, PhD | Name | Robert Havey, MS |
| Phone | (708) 202-5788 | Phone | (708) 202-3781 |
| Muturi.Muriuki@va.gov | Robert.Havey@va.gov | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68076926 | Sequence: | 68076927 | Sequence: | 68076928 |
| Design Group Id | 55534429 | Design Group Id | 55534428 | Design Group Id | 55534428 |
| Intervention Id | 52431477 | Intervention Id | 52431477 | Intervention Id | 52431478 |
Eligibilities
| Sequence: | 30734566 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study. Exclusion Criteria: Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS) scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254010458 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Number Of Primary Outcomes To Measure | 4 |
Designs
| Sequence: | 30480934 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | Double |
| Caregiver Masked | True |
| Investigator Masked | True |
Responsible Parties
| Sequence: | 28847287 |
| Responsible Party Type | Sponsor |