HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
NCT ID: NCT07223515
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2025-10-24
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Acesso DL + Standard care for DFU
Patients who received Acesso DL plus standard care for their DFU
No interventions assigned to this group
Acesso TL + Standard care for DFU
Patients who received Acesso TL plus standard care for their DFU
No interventions assigned to this group
Neostim DL + Standard care for DFU
Patients who received Neostim DL plus standard care for their DFU
No interventions assigned to this group
Neostim TL + Standard care for DFU
Patients who received Neostim TL plus standard care for their DFU
No interventions assigned to this group
Standard care alone for DFU
Patients who received standard care only for their DFU
No interventions assigned to this group
Acesso DL + Standard care for VLU
Patients who received Acesso DL plus standard care for their VLU
No interventions assigned to this group
Acesso TL + Standard care for VLU
Patients who received Acesso TL plus standard care for their VLU
No interventions assigned to this group
Neostim DL + Standard care for VLU
Patients who received Neostim DL plus standard care for their VLU
No interventions assigned to this group
Neostim TL + Standard care for VLU
Patients who received Neostim TL plus standard care for their VLU
No interventions assigned to this group
Standard care alone for VLU
Patients who received standard care only for their VLU
No interventions assigned to this group
Acesso DL + Standard care for PU
Patients who received Acesso DL plus standard care for their PU
No interventions assigned to this group
Acesso TL + Standard care for PU
Patients who received Acesso TL plus standard care for their PU
No interventions assigned to this group
Neostim DL + Standard care for PU
Patients who received Neostim DL plus standard care for their PU
No interventions assigned to this group
Neostim TL + Standard care for PU
Patients who received Neostim TL plus standard care for their PU
No interventions assigned to this group
Standard care alone for PU
Patients who received standard care only for their PU
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Dynamic Medical Services dba Acesso Biologics
INDUSTRY
Responsible Party
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Locations
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Optalis
Novi, Michigan, United States
ProCure Health
Murfreesboro, Tennessee, United States
Countries
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Other Identifiers
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AB-RWE-2025-01
Identifier Type: -
Identifier Source: org_study_id
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