Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing (NCT06632418) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
United States12 participantsStarted 2024-11-25
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Without Treatment-Related Serious Adverse Events (SAEs) at 3 Months