Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amputation; Osseointegration
• Intervention / Treatment: Drug: 5-aminolevulinic acid (5-ALA); Device: Photodynamic therapy (PDT)

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Devin Mullin; Phone Number: 603-650-6032; Email: Devin.S.Mullin@hitchcock.org
• Study Contact Backup: Name: Ida Gitajn; Phone Number: 603-650-6032; Email: Ida.Leah.Gitajn@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Osseointegration patients; All patients >18 years with osseointegrated prostheses.

Drug: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Evaluation Inventory-Short Form (TEI-SF)	The TEI-sf is a 9-item questionnaire used to measure intervention acceptability from the participants point of view. Scores range from 9 to 45, and scores above 27 are considered acceptable.	2 weeks
System Usability Scale (SUS)	The SUS is a reliable 10-item usability measure with scores that range from 0 to 100 (an above average score is 68 or higher.	2 weeks
Bioburden quantification (16S rRNA sequencing)	Bioburden will be quantified using quantitative PCR-based assays as well as addition of a "spikein" of a defined quantity of bacterial cells derived from halophilic organism Salnibacter ruber.	2 weeks
Bioburden quantification (Optical Coherence Tomography (OCT)	Biofilm will be imaged and quantified on the metal abutment	2 weeks
OCT "virtual biopsy"	Presence of inflammation, hypergranulation, and any resulting changes (e.g., the degree of epidermal regression, dermal attachment to the implant, and epithelial layer thickness) can be quantified through morphologic analysis of the OCT B-scans. Scars are characterized by excessive collagen deposition, increased blood vessel density, and parallel blood vessel organization compared with normal skin.	2 weeks
Scar thickness	Scar thickness measured using OCT	2 weeks
Blood vessel density	Blood vessel density measuring using OCT	2 weeks
Presence of hypergranulation	Hypergranulation measured using OCT	2 weeks
Pain during light exposure	Patient reported pain during light exposure	2 weeks
Discomfort, burning, itchiness, or redness	Patient reported discomfort, burning, itchiness or redness	2 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Walter Reed Army Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 28, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Amino Acids, Peptides, and Proteins; Organic Chemicals; Therapeutics; Drug Therapy; Carboxylic Acids; Amino Acids; Keto Acids; Combined Modality Therapy; Levulinic Acids; Phototherapy; Aminolevulinic Acid; Photochemotherapy
• Other Study ID Numbers: STUDY02003108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No