Amputation; Postoperative, SequelaePhase 1/2NCT04717557
Hyperbaric Oxygen and Outcome After Below Knee Amputations
A Phase 1/2 study testing Hyperbaric Oxygen in people with Amputation; Postoperative, Sequelae, run by Duke University at 1 site in United States.
Trial summary
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation; Postoperative, Sequelae
- What is being tested?
- Hyperbaric Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Able to consent
- Non-traumatic indication for lower limb amputation
- Able to receive hyperbaric oxygen therapy
Who cannot join
- Unable to consent
- Contraindication to hyperbaric oxygen
- End stage renal disease on dialysis
- Current renal failure as measured by creatinine levels vs baseline change of more than 1 mg/dL and for whom dialysis is expected to be required with the next month
- Calciphylaxis
- Traumatic injuries that are the cause of the amputation
Show all 10Show fewer
- Cancer being treated by chemotherapy, scheduled to be treated, or being treated or scheduled to be treated by radiation.
- Limb amputation secondary to ischemic complications from other operations
- Second amputation or reoperation on prior amputation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Hyperbaric Oxygen Therapy to Prevent Complications After Lower Limb Amputation
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. The objective of this study will be to compare treatment and standard care groups, randomly created of eligible patients, to compare their postoperative complications and to assess their postoperative hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
Read the detailed description
This is a clinical study to test the hypothesis that Hyperbaric Oxygen (HBO2) given in the immediate postoperative period for a total of 10 treatments after Below-the-Knee Amputation (BKA) for vascular disease will reduce postoperative complications. Patients scheduled for BKA at Duke University Medical Center will be reviewed for contraindications to HBO2. Patients for whom HBO2 is not contraindicated may choose to be enrolled in the study. Patients enrolled will be randomly assigned to receive treatment or standard postoperative care. Each patient receiving treatment will receive twice daily HBO2 for 2 hours at breathing 100% oxygen at 2 atmospheres absolute (ATA). Patients receiving HBO2 will breathe 100% oxygen via head tent while inside a hyperbaric chamber at Duke University Hospital. The statistical plan for this study will test non-directional hypotheses (two-sided tests). Bonferroni correction will be used to adjust for multiple tests. The main analysis of the primary efficacy hypotheses will include data from all randomized patients in the group to which random assignment is made. Hence, the analysis will be intention to treat. This study will primarily aim to assess whether patients receiving treatment suffer fewer complications, as defined by the Vascular Quality Initiative, vs. patients who receive standard care. The Vascular Quality Initiative (VQI) is a multicenter voluntary reporting system for outcomes related to vascular surgery. The primary outcome of this study, postoperative complications, will be those outcomes meeting the definition set out in the VQI data dictionary, the set of definitions for inclusion in the VQI database. This allows for a standard definition of complications recognized by a majority of US academic medical centers. Secondary outcomes include hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
- Conditions
- Amputation; Postoperative, Sequelae
- Being tested
- Hyperbaric Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenDrug
Also called HBO2
Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Plus Regular Care | Experimental | Hyperbaric oxygen (2 hours at 2 atmospheres absolute) to be administered 1-2 times daily for up to 10 treatments after amputation. Usual care for patients with amputation (dressing changes and treatment of infection) will be administered in parallel. Receives: Drug: Hyperbaric Oxygen |
| Regular Care | No intervention | Usual care for patients with amputation, including dressing changes and treatment of infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Mortality During the Inpatient Period
Measured: During inpatient stay immediately after amputation, up to 13 days
Number of Participants With Re-operation
Unplanned return to the OR (operating room) for a surgical procedure
Measured: Up to 90 days after amputation
Number of Participants With Wound Infection
Any wound site infection that was culture positive or required antibiotic treatment
Measured: Up to 90 days after amputation
Secondary outcomes (5)
Hospital Length of Stay
Hospital length of stay immediately after amputation
Measured: up to approximately 30 days
Number of Participants With 90-day Mortality
Death within 90 days after amputation
Measured: Up to 90 days after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery
Complete wound healing at 4 weeks after amputation
Measured: 4 weeks after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery
Complete wound healing at 8 weeks after amputation
Measured: 8 weeks after amputation
Number of Participants Able to Ambulate With Prosthesis
Ability to ambulate with a prosthesis at 6 months post amputation
Measured: 6 months after amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amputation; Postoperative, SequelaeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Permuted block
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717557
- Sponsor's protocol ID
- Pro00093687
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2021
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy to Prevent Complications After Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT04717557
- Acronym / sponsor ID
- Pro00093687
- Conditions
- Amputation; Postoperative, Sequelae
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. The objective of this study will be to compare treatment and standard care groups, randomly created of eligible patients, to compare their postoperative complications and to assess their postoperative hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
Detailed description
This is a clinical study to test the hypothesis that Hyperbaric Oxygen (HBO2) given in the immediate postoperative period for a total of 10 treatments after Below-the-Knee Amputation (BKA) for vascular disease will reduce postoperative complications. Patients scheduled for BKA at Duke University Medical Center will be reviewed for contraindications to HBO2. Patients for whom HBO2 is not contraindicated may choose to be enrolled in the study. Patients enrolled will be randomly assigned to receive treatment or standard postoperative care. Each patient receiving treatment will receive twice daily HBO2 for 2 hours at breathing 100% oxygen at 2 atmospheres absolute (ATA). Patients receiving HBO2 will breathe 100% oxygen via head tent while inside a hyperbaric chamber at Duke University Hospital. The statistical plan for this study will test non-directional hypotheses (two-sided tests). Bonferroni correction will be used to adjust for multiple tests. The main analysis of the primary efficacy hypotheses will include data from all randomized patients in the group to which random assignment is made. Hence, the analysis will be intention to treat. This study will primarily aim to assess whether patients receiving treatment suffer fewer complications, as defined by the Vascular Quality Initiative, vs. patients who receive standard care. The Vascular Quality Initiative (VQI) is a multicenter voluntary reporting system for outcomes related to vascular surgery. The primary outcome of this study, postoperative complications, will be those outcomes meeting the definition set out in the VQI data dictionary, the set of definitions for inclusion in the VQI database. This allows for a standard definition of complications recognized by a majority of US academic medical centers. Secondary outcomes include hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Permuted block
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Plus Regular Care | Experimental | Drug: Hyperbaric OxygenHyperbaric oxygen (2 hours at 2 atmospheres absolute) to be administered 1-2 times daily for up to 10 treatments after amputation. Usual care for patients with amputation (dressing changes and treatment of infection) will be administered in parallel. |
| Regular Care | No intervention | –Usual care for patients with amputation, including dressing changes and treatment of infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to consent
- Non-traumatic indication for lower limb amputation
- Able to receive hyperbaric oxygen therapy
Key exclusion criteria (10 listed)
- Unable to consent
- Contraindication to hyperbaric oxygen
- End stage renal disease on dialysis
- Current renal failure as measured by creatinine levels vs baseline change of more than 1 mg/dL and for whom dialysis is expected to be required with the next month
- Calciphylaxis
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 |
|---|---|---|
| Hyperbaric OxygenAlso: HBO2Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation | Drug | Hyperbaric Oxygen Plus Regular Care |
Primary outcome
Number of Participants With Mortality During the Inpatient Period
Time frame: During inpatient stay immediately after amputation, up to 13 days
Number of Participants With Re-operation
Time frame: Up to 90 days after amputation
Unplanned return to the OR (operating room) for a surgical procedure
Number of Participants With Wound Infection
Time frame: Up to 90 days after amputation
Any wound site infection that was culture positive or required antibiotic treatment
5 secondary outcomes
Hospital Length of Stay
Time frame: up to approximately 30 days
Number of Participants With 90-day Mortality
Time frame: Up to 90 days after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery
Time frame: 4 weeks after amputation
Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery
Time frame: 8 weeks after amputation
Number of Participants Able to Ambulate With Prosthesis
Time frame: 6 months after amputation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperbaric Oxygen in people with Amputation; Postoperative, Sequelae, run by Duke University 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Aug 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Mortality During the Inpatient Period (time frame: During inpatient stay immediately after amputation, up to 13 days). The study lists 3 primary outcomes in all. 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 11 Aug 2025.