Observational Study of Photodynamic Therapy for Osseointegrated Prosthesis Infection Prevention

This observational study is looking at a new way to prevent infections around osseointegrated prostheses (a type of artificial limb that connects directly to the bone). It will involve 10 patients aged 18 or older who have an osseointegrated prosthesis and do not have an active infection or are pregnant. The study will test if using 5-aminolevulinic acid (5-ALA) cream along with a light device (photodynamic therapy or PDT) can help prevent infections. This treatment will be part of your regular care for the stoma (the opening where the prosthesis connects). The main goal is to see if this treatment is practical to use, and this will be checked after 2 weeks. The study is currently unclear on its recruitment status.

Study design
This is an observational study involving 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would apply topical 5-ALA cream and use a light delivery device as part of your daily stoma management. The first treatment will be at the clinic, and all others will be done at home.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the treatment will be measured at 2 weeks.

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NCT06777511

Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

Not Yet Recruiting
Not specifiedAges 18+Observational
Dartmouth-Hitchcock Medical Center
~10 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:5-aminolevulinic acid (5-ALA)Photodynamic therapy (PDT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility
Measured over 2 weeks
Amputation
Osseointegration
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

All patients with osseointegrated prostheses 18 years of age or older

Exclusion

Ongoing infection
Pregnant
Anticipated issues with compliance or follow-up
  • Feasibility2 weeks

    Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.