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

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.

Conditions

Anal Fistula, Complex Perianal Fistula

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anal Fistula
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of a single tract perianal fistula not amenable to fistulotomy as determined by the supervising surgeon
  • * Fistula must currently have a draining seton in place
  • * Aged \>21 years old
  • * Willing and able to provide informed consent and to comply with study protocol and follow-up
  • * Stated willingness to comply with all study procedures and availability for the duration of the study
  • * 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
  • * Genito-urinary fistulization, including rectovaginal (i.e., fistulas that transverse the vaginal canal)
  • * Presence of an ileal anal pouch
  • * 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
  • * 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
  • * 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.
  • * Known allergic reactions to porcine collagen or yeast-derived products
  • * 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
  • * Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
  • * Active infection at the application site
  • * The presence of malignant neoplasms at the application site
  • * Prior radiation therapy at the application site

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexander Hawkins,

Alexander T Hawkins, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2026-01