RECRUITING

Evaluating an RhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing

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Conditions

Anal FistulaComplex Perianal FistulaPlatelet-derived Growth FactorType 1 CollagenAnal fistula plug

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derived growth factor drives wound healing and tissue regeneration, and manufactured PDGF is currently used to heal diabetic foot ulcers and regenerate bone in periodontal and orthopedic patients. Manufactured recombinant human PDGF has the potential to improve the success rate for complete healing of complex perianal fistulas, reduce the recurrence rate due to reopening of the fistula tract, and avoid complications associated with routine surgical interventions.

Official Title

A Randomized Controlled Trial Evaluating the Safety and Feasibility of the Recombinant Human Platelet-derived Growth Factor B (rhPDGF-BB)-enhanced Collagen Plug for Complex Perianal Fistula Healing

Quick Facts

Study Start:2024-11-25
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06632418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of a single tract perianal fistula not amenable to fistulotomy as determined by the supervising surgeon
  2. * Fistula must currently have a draining seton in place
  3. * Aged \>21 years old
  4. * Willing and able to provide informed consent and to comply with study protocol and follow-up
  5. * Stated willingness to comply with all study procedures and availability for the duration of the study
  1. * Medical conditions that would, in the opinion of the investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol
  2. * Genito-urinary fistulization, including rectovaginal (i.e., fistulas that transverse the vaginal canal)
  3. * Presence of an ileal anal pouch
  4. * Any major surgery of the gastrointestinal tract (including one or more segments of the colon or terminal ileum) within 3 months prior to randomization; presence of stoma is not exclusionary
  5. * Prior surgical procedure (i.e., Ligation of Intersphincteric Fistula Tract or Endorectal Advancement Flap) for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit
  6. * One or more of the following fistula types or anatomic presentations: horseshoe fistulas, fistulas that do not have an opening inside the anal canal or low rectum, blind ending sinus tracts (no external opening), branching fistulas (a previously performed conversion of a branching fistula tract to a single tract is not exclusionary), \>1 internal opening, moderate or severe proctitis, severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug disk, any anatomical limitation to successfully securing the fistula plug disk.
  7. * Known allergic reactions to porcine collagen or yeast-derived products
  8. * Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in or near the fistula tract or may potentially interact with study treatment
  9. * Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
  10. * Active infection at the application site
  11. * The presence of malignant neoplasms at the application site
  12. * Prior radiation therapy at the application site

Contacts and Locations

Study Contact

Jacob J Smith
CONTACT
615-875-7466
jacob.smith@vumc.org
Cyndi R Clark, PhD
CONTACT
cyndi.r.clark@vumc.org

Principal Investigator

Alexander T Hawkins
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Alexander Hawkins

  • Alexander T Hawkins, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Platelet-derived Growth Factor
  • Type 1 Collagen
  • Anal fistula plug

Additional Relevant MeSH Terms

  • Anal Fistula
  • Complex Perianal Fistula