An observational study in Amputation and Osseointegration, sponsored by Dartmouth-Hitchcock Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Dartmouth-Hitchcock Medical Center · Observational
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.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
All patients \>18 years with osseointegrated prostheses.
Drug: 5-aminolevulinic acid (5-ALA) · 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 as part of their standard stoma management.
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.
Feasibility
Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.
Time frame: 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
Bioburden quantification (Optical Coherence Tomography (OCT)
Biofilm will be imaged and quantified on the metal abutment
Time frame: 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.
Time frame: 2 weeks
Scar thickness
Scar thickness measured using OCT
Time frame: 2 weeks
Blood vessel density
Blood vessel density measuring using OCT
Time frame: 2 weeks
Presence of hypergranulation
Hypergranulation measured using OCT
Time frame: 2 weeks
Pain during light exposure
Patient reported pain during light exposure
Time frame: 2 weeks
Discomfort, burning, itchiness, or redness
Patient reported discomfort, burning, itchiness or redness
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center