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low enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Regular Care | No Intervention | Usual care for patients with amputation, including dressing changes and treatment of infection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Drug | Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mortality During the Inpatient Period | 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 | Up to 90 days after amputation |
| Number of Participants With Wound Infection | Any wound site infection that was culture positive or required antibiotic treatment | Up to 90 days after amputation |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Hospital length of stay immediately after amputation | up to approximately 30 days |
| Number of Participants With 90-day Mortality | Death within 90 days after amputation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital Readmission | Any readmission to hospital after initial discharge | Up to 90 days after amputation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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Recruitment was in hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperbaric Oxygen Plus Regular Care | 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 will be administered in parallel. Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation |
| FG001 | Regular Care | Usual care for patients with amputation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperbaric Oxygen Plus Regular Care | 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 will be administered in parallel. Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Mortality During the Inpatient Period | Posted | Count of Participants | Participants | During inpatient stay immediately after amputation, up to 13 days |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperbaric Oxygen Plus Regular Care | 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 will be administered in parallel. Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation |
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Due to insufficient recruitment the study was terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Moon | Duke University | 919-684-8762 | 9199065651 | richard.moon@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2024 | Jul 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2023 | Jul 7, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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Permuted block
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| 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 | 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 | 8 weeks after amputation |
| Number of Participants Able to Ambulate With Prosthesis | Ability to ambulate with a prosthesis at 6 months post amputation | 6 months after amputation |
| BG001 |
| Regular Care |
Usual care for patients with amputation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants With Re-operation | Unplanned return to the OR (operating room) for a surgical procedure | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | Up to 90 days after amputation |
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| Primary | Number of Participants With Wound Infection | Any wound site infection that was culture positive or required antibiotic treatment | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | Up to 90 days after amputation |
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| Secondary | Hospital Length of Stay | Hospital length of stay immediately after amputation | Posted | Mean | Full Range | days | up to approximately 30 days |
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| Secondary | Number of Participants With 90-day Mortality | Death within 90 days after amputation | Posted | Count of Participants | Participants | Up to 90 days after amputation |
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| Secondary | Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery | Complete wound healing at 4 weeks after amputation | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | 4 weeks after amputation |
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| Secondary | Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery | Complete wound healing at 8 weeks after amputation | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | 8 weeks after amputation |
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| Secondary | Number of Participants Able to Ambulate With Prosthesis | Ability to ambulate with a prosthesis at 6 months post amputation | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | 6 months after amputation |
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| Other Pre-specified | Number of Participants With Hospital Readmission | Any readmission to hospital after initial discharge | One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation. | Posted | Count of Participants | Participants | Up to 90 days after amputation |
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| 1 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Regular Care | Usual care for patients with amputation. | 0 | 1 | 0 | 1 | 0 | 1 |
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