Actively Recruiting
Evaluation of Combination Therapy for Upper Extremity Lymphedema
Led by Stanford University · Updated on 2025-12-24
60
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Combination Therapy for Upper Extremity Lymphedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 75 years (inclusive)
- Life expectancy greater than 2 years
- Upper limb lymphedema
- Eligible for surgical intervention
- Swelling of one limb not completely reversed by elevation or compression
- Stage I-II lymphedema at screening based on International Society of Lymphology staging
- Participants with cancer history must have no evidence of disease and completed breast cancer therapy at least 3 years prior; endocrine therapy allowed
- Completed full course of complete decongestive therapy at least 12 weeks prior, including consistent compression garment use
- Willingness to comply with self-care and consistent daytime compression garment use throughout the study, except first 3 weeks post-surgery
- Limb volume difference of at least 10% between affected and unaffected limb
- Evidence of abnormal bioimpedance ratio, if measurable (L Dex > 10 units)
- Ability and willingness to undergo all study procedures including limb volume measurement, skin biopsy, and imaging
- Ability to understand and sign informed consent
You will not qualify if you...
- Edema caused by increased capillary filtration (e.g., venous incompetence)
- Unable to safely undergo general anesthesia or perioperative care for lymph node transfer
- Participation in another investigational drug or therapy trial within 1 month or 5 drug half-lives before screening
- Started complete decongestive physical therapy within 12 weeks prior
- Medical conditions causing acute limb edema such as venous thrombosis or heart failure
- Conditions causing symptoms overlapping lymphedema like pain, swelling, or decreased motion
- History of clotting disorder
- Persistent infection in the affected limb
- Infection in lymphedema limb within 1 month prior to screening
- Currently receiving chemotherapy or radiation therapy
- Body Mass Index over 35
- Known allergy to porcine products
- Anaphylaxis to iodine
- Pregnancy or nursing
- Substance abuse within 6 months prior
- Any other reason deemed by investigator to prevent full study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
D
Dung Nguyen, MD, PharmD
CONTACT
E
Elizabeth Tadevosyan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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