Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515093
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Study Assessing Complete Wound Healing by Comparing Surgenex PelloGraft in Treating DFU and SanoGraft in Treating VLU to SOC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex PelloGraft in Treating Diabetic Foot Ulcers DFU and SanoGraft in Treating Venous Leg Ulcers VLU to SOC Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects and to compare Sanograft to standard of care in treating venous leg ulcers The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization decrease in wound size and total number of study product applications towards healing outcome This information is important to the Centers for Medicare and Medicaid Services CMS and other payors in determining coverage policy and reimbursement for this product category
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None