Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

NCT ID: NCT06777511

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-03-28

Brief Summary

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD.

All eligible consenting patients will undergo daily stoma management per standard of care.

Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes.

Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes.

Follow-up: Study participants will be followed at 1 week and 2 weeks.

Conditions

Amputation; Osseointegration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Osseointegration patients

All patients \>18 years with osseointegrated prostheses.

5-aminolevulinic acid (5-ALA)

Intervention Type: DRUG

All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device as part of their standard stoma management.

Photodynamic therapy (PDT)

Intervention Type: DEVICE

All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device photodynamic therapy device as part of their standard stoma management.

Interventions

5-aminolevulinic acid (5-ALA)

All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device as part of their standard stoma management.

Intervention Type: DRUG

Photodynamic therapy (PDT)

All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device photodynamic therapy device as part of their standard stoma management.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients with osseointegrated prostheses 18 years of age or older

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ida Leah Gitajn

Section Chief, Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Devin Mullin

Role: CONTACT

Devin.S.Mullin@hitchcock.org

603-650-6032

Ida Gitajn

Role: CONTACT

Ida.Leah.Gitajn@hitchcock.org

603-650-6032

Other Identifiers

STUDY02003108

Identifier Type: -

Identifier Source: org_study_id