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Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Chronic non-healing venous leg ulcers (VLUs) have an intrinsic healing impairment that is associated with dysfunctional gene expression patterns. The previous study has shown that tissue from the non-healing edge of chronic VLUs exhibits characteristic histopathology including epidermal hyperproliferation, dermal fibrosis, accumulation of intracellular pro-collagen and dysregulation of genes involved in epidermal differentiation, migration and proliferation. It also has demonstrated that biopsies taken from the non-healing edges of VLUs before and after debridement have distinct morphologies and distinguishable gene expression patterns, providing the biological basis and justification of debridement. These observations are supported by the findings that primary cells grown from tissue biopsies before and after debridement also have distinct and typical genomic patterns, with cells from pre-debridement edge biopsies exhibiting a non-healing phenotype as evidenced by loss of migration and loss of ability to respond to growth factor stimuli. Moreover, using a genomic approach in a clinical trial to determine mechanism of action of cell-based therapy in patients with VLU, the study team has identified a specific set of genes responsible for therapeutic reprogramming that shifts non-healing ulcer into acute wound-like healing VLU. The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing VLUs and to test the efficacy of this approach.

The study hypothesizes that genes (their transcription level or protein patterns) can be utilized to guide wound edge debridement in patients with VLUs and further that such guided debridement will improve healing outcome in patients suffering from chronic non-healing VLUs. Moreover, the team proposes to use genomic profiles to further advance and guide development of PCR-based approach or immunostains that can serve as a simplified diagnostic test to identify debridement margin and non-healing VLUs tissue.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • >18 years of age
  • Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)
  • have a venous ulcer between the knee and ankle, at or above the malleolus
  • wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone
  • wound duration of at least 6 months
  • VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue
  • ability of subject to tolerate limb compression bandage

Exclusion Criteria:

  • history of diabetes mellitus and a HbA1c > 12% (obtained within past 6 months)
  • Ankle brachial index(ABI) less than 0.80
  • any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
  • suspicion of malignancy within VLU
  • life expectancy <6 months
  • history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
  • history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) >2x upper limit of normal (obtained within past 6 months)
  • requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
  • history of immunodeficiency
  • ulcers due to none venous etiology and leg ulcers associated with mixed etiology
  • Untreated osteomyelitis
  • Hepatitis
  • acute deep venous thrombosis
  • allergy to lidocaine and/or epinephrine
  • Subject's inability to successfully tolerate compression therapy that is changed weekly
  • Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
  • if currently incarcerated
  • known pregnancy

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Basic Science

Study Location(s):

University of Miami, Miami, Florida, United States, 33136

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03796793?term=NCT03796793&rank=1

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