Using a collagen plug enhanced with growth factor to heal complex anal fistulas
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
This study is testing whether a special collagen plug with growth factors can help heal complex anal fistulas in people who can't have surgery, especially those with Crohn's disease or other unknown causes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06632418 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the effectiveness and safety of a recombinant human platelet-derived growth factor (rhPDGF-BB) enhanced collagen plug for healing complex perianal fistulas that are not suitable for surgical intervention. Participants will be randomly assigned to receive either the rhPDGF-BB-enhanced plug or routine care, with a focus on those with fistulas related to Crohn's disease or idiopathic causes. The study aims to improve healing rates and reduce complications associated with traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with a single tract perianal fistula that cannot be treated with fistulotomy and currently have a draining seton in place.
Not a fit: Patients with genito-urinary fistulas, ileal anal pouches, or those who have had major gastrointestinal surgery recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients with complex perianal fistulas, reducing the need for invasive surgeries.
How similar studies have performed: While the use of growth factors in wound healing has shown promise in other contexts, this specific application for perianal fistulas is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Alexander T Hawkins — Vanderbilt University Medical Center
- Study coordinator: Jacob J Smith
- Email: jacob.smith@vumc.org
- Phone: 615-875-7466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.