search
Back to results

Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

Primary Purpose

Lymphedema Arm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioBridge
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema Arm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Ages 18 to 75 years (inclusive) Life expectancy > 2 years Upper limb lymphedema The participant must be eligible for surgical intervention Swelling of 1 limb that is not completely reversed by elevation or compression Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system Participants with a history of cancer must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed. Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration. Consistent use of an appropriately sized compression garment for daytime use. Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other. Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units. Willingness and ability to comply with all study procedures, including measurement of limb volume, skin biopsy, and preoperative and postoperative imaging studies. Willingness and ability to understand, and to sign a written informed consent form document Exclusion Criteria: Edema arising from increased capillary filtration will be excluded (venous incompetence). Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer Recent initiation (≤ 12 weeks) of CDPT for lymphedema Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion) History of clotting disorder (hypercoagulable state) Chronic (persistent) infection in the affected limb Infection of the lymphedema limb within 1 month prior to screening Currently receiving chemotherapy or radiation therapy Body Mass Index (BMI) >35 Known sensitivity to porcine products Anaphylaxis to iodine Pregnancy or nursing Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    VLNT

    VLNT with Biobridge

    Arm Description

    Standard of care vascularized lymph node transfer

    Standard of care vascularized lymph node transfer plus BioBridge placement

    Outcomes

    Primary Outcome Measures

    Improve the outcome of surgical treatment of upper extremity lymphedema
    To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema
    Improve the outcome of surgical treatment of upper extremity lymphedema
    Primary endpoint is % change in (excess) limb volume, from baseline to Month 12, in the intervention group relative to control group. Dispersion (variance) will be assessed as the standard deviation.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2022
    Last Updated
    April 20, 2023
    Sponsor
    Stanford University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05825157
    Brief Title
    Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
    Official Title
    Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2026 (Anticipated)
    Study Completion Date
    January 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    Brief Summary
    Investigate whether the addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. Will Biobridge improve upon the low success rate of the currently practiced surgery by facilitating the lymphatic connections to the transplanted node that are crucial to its viability and function.
    Detailed Description
    Secondary lymphedema is the most common cause of lymphedema in the western world. Vascularized lymph node transfer (VLNT) is currently practiced with increasing frequency in the human disease population. This study will determined the efficacy of the Biobridge when used with VLNT in the human subjects with lymphedema; efficacy in large animal models has already been demonstrated. Patients with lymphedema who had BioBridge placed for soft tissue reinforcement after scar release has been observed to have improved lymph drainage and improvement of their limb volume.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema Arm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    VLNT or VLNT with BioBridge placement
    Masking
    Participant
    Masking Description
    patients will be blinded and be randomized via a blocked randomization design. Approximately 60 patients will be randomized in a 4:1 ratio to the intervention arm (VLNT + BioBridge): control arm (VLNT alone). Randomization will be done within blocks (of size 5) so that the balance between treatments is preserved throughout the trial.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VLNT
    Arm Type
    Active Comparator
    Arm Description
    Standard of care vascularized lymph node transfer
    Arm Title
    VLNT with Biobridge
    Arm Type
    Experimental
    Arm Description
    Standard of care vascularized lymph node transfer plus BioBridge placement
    Intervention Type
    Device
    Intervention Name(s)
    BioBridge
    Intervention Description
    Fibralign BioBridge is a thread-like, multi-lumen scaffold consisting of highly aligned collagen fibrils, optimized to encourage the endothelial cell attachment,alignment and migration that are prerequisites to new vessel formation. BioBridge is a device made from highly purified, medical-grade porcine collagen.
    Primary Outcome Measure Information:
    Title
    Improve the outcome of surgical treatment of upper extremity lymphedema
    Description
    To measure the post-surgical percent change in excess limb volume measured at 12 months following surgery using BioBridge scaffold as an adjunct to vascularized lymph node transfer for treatment of upper extremity lymphedema
    Time Frame
    12 months
    Title
    Improve the outcome of surgical treatment of upper extremity lymphedema
    Description
    Primary endpoint is % change in (excess) limb volume, from baseline to Month 12, in the intervention group relative to control group. Dispersion (variance) will be assessed as the standard deviation.
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages 18 to 75 years (inclusive) Life expectancy > 2 years Upper limb lymphedema The participant must be eligible for surgical intervention Swelling of 1 limb that is not completely reversed by elevation or compression Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system Participants with a history of cancer must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed. Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration. Consistent use of an appropriately sized compression garment for daytime use. Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other. Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units. Willingness and ability to comply with all study procedures, including measurement of limb volume, skin biopsy, and preoperative and postoperative imaging studies. Willingness and ability to understand, and to sign a written informed consent form document Exclusion Criteria: Edema arising from increased capillary filtration will be excluded (venous incompetence). Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer Recent initiation (≤ 12 weeks) of CDPT for lymphedema Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion) History of clotting disorder (hypercoagulable state) Chronic (persistent) infection in the affected limb Infection of the lymphedema limb within 1 month prior to screening Currently receiving chemotherapy or radiation therapy Body Mass Index (BMI) >35 Known sensitivity to porcine products Anaphylaxis to iodine Pregnancy or nursing Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prospective Evaluation of Combination Therapy for Upper Extremity Lymphedema

    We'll reach out to this number within 24 hrs