Trial Outcomes & Findings for Hyperbaric Oxygen and Outcome After Below Knee Amputations (NCT NCT04717557)
NCT ID: NCT04717557
Last Updated: 2025-08-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
During inpatient stay immediately after amputation, up to 13 days
Results posted on
2025-08-11
Participant Flow
Recruitment was in hospital.
Participant milestones
| Measure |
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
|
Regular Care
Usual care for patients with amputation.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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
|
Regular Care
Usual care for patients with amputation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Hyperbaric Oxygen and Outcome After Below Knee Amputations
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=3 Participants
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
|
Regular Care
n=1 Participants
Usual care for patients with amputation.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
52 years
n=99 Participants
|
74 years
n=107 Participants
|
57.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During inpatient stay immediately after amputation, up to 13 daysOutcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=3 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Mortality During the Inpatient Period
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Unplanned return to the OR (operating room) for a surgical procedure
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Re-operation
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Any wound site infection that was culture positive or required antibiotic treatment
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Wound Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to approximately 30 daysHospital length of stay immediately after amputation
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=3 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Hospital Length of Stay
|
5.3 days
Interval 4.0 to 7.0
|
13 days
Interval 13.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 90 days after amputationDeath within 90 days after amputation
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=3 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With 90-day Mortality
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Complete wound healing at 4 weeks after amputation
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Complete Healing of Amputation Wound Healing at 4 Weeks Following Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Complete wound healing at 8 weeks after amputation
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Complete Healing of Amputation Wound Healing at 8 Weeks Following Surgery
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Ability to ambulate with a prosthesis at 6 months post amputation
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants Able to Ambulate With Prosthesis
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 days after amputationPopulation: One participant in the Hyperbaric Oxygen Plus Regular Care arm died following amputation.
Any readmission to hospital after initial discharge
Outcome measures
| Measure |
Hyperbaric Oxygen Plus Regular Care
n=2 Participants
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.
Hyperbaric Oxygen: Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
|
Regular Care
n=1 Participants
Usual care for patients with amputation, including dressing changes and treatment of infection.
|
|---|---|---|
|
Number of Participants With Hospital Readmission
|
0 Participants
|
1 Participants
|
Adverse Events
Hyperbaric Oxygen Plus Regular Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Regular Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place