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Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers (ASCEND)

Primary Purpose

Diabetic Foot Ulcer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ADRCs
standard care
Placebo
Sponsored by
Paracrine, INC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T1D or T2D
  • Diabetic Foot Ulcer, from 1 to 12 months in duration
  • Wagner Grade 1 or Superficial 2
  • Adequate perfusion
  • Able to undergo liposuction

Exclusion Criteria:

  • Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
  • Active infection
  • Non-diabetic neuropathy
  • Significant cardiovascular event within 6 months before screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Standard Care plus ARDCs

    Standard Care plus Placebo

    Arm Description

    All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. All patients will receive standard care for their Diabetic Foot Ulcer. Additionally, patients randomized to the ADRC arm will receive ADRCs

    All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. All patients will receive standard care for their Diabetic Foot Ulcer. Additionally, patients randomized to the Control arm will receive Placebo

    Outcomes

    Primary Outcome Measures

    DFU Closure Rate
    The rate of closure at 12 Weeks

    Secondary Outcome Measures

    Percent Reduction of Wound Area
    Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed

    Full Information

    First Posted
    October 15, 2021
    Last Updated
    September 26, 2022
    Sponsor
    Paracrine, INC.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05095389
    Brief Title
    Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers
    Acronym
    ASCEND
    Official Title
    Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 28, 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Paracrine, INC.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
    Detailed Description
    Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care. Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo). ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure. The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcer
    Keywords
    Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, Parallel-Group, Double-Blind, Placebo Controlled
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Placebo is visually indistinguishable from Active Treatment. Every patient receives Standard Care, plus either Active Treatment or Placebo.
    Allocation
    Randomized
    Enrollment
    290 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care plus ARDCs
    Arm Type
    Experimental
    Arm Description
    All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. All patients will receive standard care for their Diabetic Foot Ulcer. Additionally, patients randomized to the ADRC arm will receive ADRCs
    Arm Title
    Standard Care plus Placebo
    Arm Type
    Active Comparator
    Arm Description
    All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. All patients will receive standard care for their Diabetic Foot Ulcer. Additionally, patients randomized to the Control arm will receive Placebo
    Intervention Type
    Device
    Intervention Name(s)
    ADRCs
    Intervention Description
    Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
    Intervention Type
    Other
    Intervention Name(s)
    standard care
    Intervention Description
    standard care
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    DFU Closure Rate
    Description
    The rate of closure at 12 Weeks
    Time Frame
    12 Weeks
    Secondary Outcome Measure Information:
    Title
    Percent Reduction of Wound Area
    Description
    Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed
    Time Frame
    12 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T1D or T2D Diabetic Foot Ulcer, from 1 to 12 months in duration Wagner Grade 1 or Superficial 2 Adequate perfusion Able to undergo liposuction Exclusion Criteria: Diabetic Foot Ulcer penetrates to capsule, tendon, or bone Active infection Non-diabetic neuropathy Significant cardiovascular event within 6 months before screening

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No IPD/PHI will be made available

    Learn more about this trial

    Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

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