Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567563
Status:
UNKNOWN
Last Update Posted:
2020-09-28
First Post:
2020-09-17
Brief Title:
Remote Ischemic Conditioning and Diabetic Foot Ulcers
Sponsor:
Des Moines University
Organization:
Des Moines University
Study Overview
Official Title:
The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study type Randomized double blinded interventional single-site study Two groups Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC
Study population Adults 18 to 90 with diabetes myelitis presenting with diabetic foot ulcers
Randomization and sample size Subjects will be allocated on a 11 ratio yielding a minimum per protocol population PP Population of 15 patients in the Active group and 15 in the control group
Study timeline Total amount of time from the Screening Visit to the Final Visit is approximately 16 weeks For patients who meet inclusion criteria they are randomized into Active or Control treatment groups In addition they are stratified into groups based on wound etiology neuropathic defined as insensate at 2 or more of 5 sites verified by insensitivity to the 507 Semmes-Weinstein 10 g monofilament ischemic defined as ABI of 07 neuro-ischemic meeting both of above criteria Subjects will present at DMU Foot and Ankle Clinic on weeks 0 3 6 9 and 12 for the following measurements 40mL venous blood draw VEGF SDF1a 2mm punch biopsy CD34 Local wound perfusion Laser SpeckleFK2 Ulcer size measured by digital planimetry TissueAnalytics
Study population Adults 18 to 90 with diabetes myelitis presenting with diabetic foot ulcers
Randomization and sample size Subjects will be allocated on a 11 ratio yielding a minimum per protocol population PP Population of 15 patients in the Active group and 15 in the control group
Study timeline Total amount of time from the Screening Visit to the Final Visit is approximately 16 weeks For patients who meet inclusion criteria they are randomized into Active or Control treatment groups In addition they are stratified into groups based on wound etiology neuropathic defined as insensate at 2 or more of 5 sites verified by insensitivity to the 507 Semmes-Weinstein 10 g monofilament ischemic defined as ABI of 07 neuro-ischemic meeting both of above criteria Subjects will present at DMU Foot and Ankle Clinic on weeks 0 3 6 9 and 12 for the following measurements 40mL venous blood draw VEGF SDF1a 2mm punch biopsy CD34 Local wound perfusion Laser SpeckleFK2 Ulcer size measured by digital planimetry TissueAnalytics
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None