| NCT ID | NCT06310239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Walter Reed National Military Medical Center |
| Condition | Amputation With Osseointegration |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-12-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole.
Eligibility Criteria
Inclusion Criteria: * Any adult male or female that will undergo an OI procedure between the ages of 18-75. * Defense Enrollment Eligibility Reporting System (DEERs) eligible Exclusion Criteria: * Inability to provide self-consent
Contact & Investigator
Ean R Saberski, MD
PRINCIPAL INVESTIGATOR
Walter Reed National Military Medical Center
Frequently Asked Questions
Who can join the NCT06310239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Amputation With Osseointegration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06310239 currently recruiting?
Yes, NCT06310239 is actively recruiting participants. Contact the research team at Ean.saberski.mil@health.mil for enrollment information.
Where is the NCT06310239 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06310239 clinical trial?
NCT06310239 is sponsored by Walter Reed National Military Medical Center. The principal investigator is Ean R Saberski, MD at Walter Reed National Military Medical Center. The trial plans to enroll 50 participants.