AmputationNCT06777511
Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
An observational study of Amputation and Osseointegration, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Osseointegration
- What is being tested?
- 5-aminolevulinic acid (5-ALA) and Photodynamic therapy (PDT)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients with osseointegrated prostheses 18 years of age or older
Who cannot join
- Ongoing infection
- Pregnant
- Anticipated issues with compliance or follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Christopher H Renninger, MD, (202)-929-0618, christopher.h.renninger.mil@health.mil
Qingfeng Liu, (240) 645-3068, Qingfeng.liu.ctr@usuhs.edu
About this study
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.
Read more
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
- Being tested
- 5-aminolevulinic acid (5-ALA), Photodynamic therapy (PDT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Osseointegration patients | All patients >18 years with osseointegrated prostheses. Receives: Drug: 5-aminolevulinic acid (5-ALA); Device: Photodynamic therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.
Measured: 2 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Bioburden quantification (Optical Coherence Tomography (OCT)
Biofilm will be imaged and quantified on the metal abutment
Measured: 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.
Measured: 2 weeks
Scar thickness
Scar thickness measured using OCT
Measured: 2 weeks
Blood vessel density
Blood vessel density measuring using OCT
Measured: 2 weeks
Presence of hypergranulation
Hypergranulation measured using OCT
Measured: 2 weeks
Pain during light exposure
Patient reported pain during light exposure
Measured: 2 weeks
Discomfort, burning, itchiness, or redness
Patient reported discomfort, burning, itchiness or redness
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Responsible party
- Principal investigator, Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777511
- Sponsor's protocol ID
- STUDY02003108
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
- ClinicalTrials.gov ID
- NCT06777511
- Acronym / sponsor ID
- STUDY02003108
- Conditions
- Amputation, Osseointegration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osseointegration patients | – | Drug: 5-aminolevulinic acid (5-ALA), Device: Photodynamic therapy (PDT)All patients >18 years with osseointegrated prostheses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients with osseointegrated prostheses 18 years of age or older
Key exclusion criteria (3 listed)
- Ongoing infection
- Pregnant
- Anticipated issues with compliance or follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Osseointegration patients |
| 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. | Device | Osseointegration patients |
Primary outcome
Feasibility
Time frame: 2 weeks
Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.
10 secondary outcomes
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time frame: 2 weeks
System Usability Scale (SUS)
Time frame: 2 weeks
Bioburden quantification (16S rRNA sequencing)
Time frame: 2 weeks
Bioburden quantification (Optical Coherence Tomography (OCT)
Time frame: 2 weeks
OCT "virtual biopsy"
Time frame: 2 weeks
Scar thickness
Time frame: 2 weeks
Blood vessel density
Time frame: 2 weeks
Presence of hypergranulation
Time frame: 2 weeks
Pain during light exposure
Time frame: 2 weeks
Discomfort, burning, itchiness, or redness
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Osseointegration, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devin Mullin (603-650-6032, Devin.S.Mullin@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.