Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

NCT06777511 | Not Yet Recruiting

• 1 other identifier: STUDY02003108
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

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

  2 weeks

Secondary Outcomes (10)

• Treatment Evaluation Inventory-Short Form (TEI-SF)

  2 weeks

• System Usability Scale (SUS)

  2 weeks

• Bioburden quantification (16S rRNA sequencing)

  2 weeks

• Bioburden quantification (Optical Coherence Tomography (OCT)

  2 weeks

• OCT "virtual biopsy"

  2 weeks

Study Arms (1)

Osseointegration patients

All patients \>18 years with osseointegrated prostheses.

Drug: 5-aminolevulinic acid (5-ALA); Device: Photodynamic therapy (PDT)

Interventions

5-aminolevulinic acid (5-ALA) 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.

Osseointegration patients

Photodynamic therapy (PDT) 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.

Osseointegration patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients \>18 years with osseointegrated prostheses are eligible. Patients will be excluded if they have an ongoing infection, are pregnant or if it is anticipate that they will have issues with compliance or follow-up.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Walter Reed Army Medical Center: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

swab specimens of the stoma site, collected for determining bacterial bioburden

MeSH Terms

Interventions

Aminolevulinic Acid; Photochemotherapy

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Central Study Contacts

Devin Mullin

CONTACT

603-650-6032; Devin.S.Mullin@hitchcock.org

Ida Gitajn

CONTACT

603-650-6032; Ida.Leah.Gitajn@hitchcock.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Orthopaedics

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share