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Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

StatusActive, Not Recruiting
PhasePhase 4
Started2017-10-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 27, 2026 (before its estimated July 12, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-24
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-12-31→2026-07-12
Completion date2026-12-31→2026-07-12
Study sitesdetails revised at 1 of 1 site
2025-07-07
Study Status, Oversight, IPDSharing v9
Re-verified, no change to tracked fields
2024-06-04
Study Status v8
Primary completion date2024-12-31→2026-12-31
Completion date2024-12-31→2026-12-31
2023-07-07
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v7
Eligibility criteria+15 characters
[...] uncontrolled diabetes mellitus (documentation of history of DMdiabetes mellitus with A1c>8) Active deep vein thrombosis in the treatment ex [...]
Secondary endpoints3 to 6 entries
SurgicalFrequency of surgical site infections or periprosthetic infections Localfrequency wound management Reoperation due toof wound complications that result in a secondary procedure Wound Severity Frequency of delayed wound healing Variability in Patient Reported Quality of Life Variability in Patient Reported Wound Assessments
Primary endpoints1 to 6 entries
Hyperbaric Treatment Completion Rate Participant Assessment Form Completion Rate Recruitment rate Wound ComplicationsAssessment Form Completion Rate barriers to compliance with study procedures patient reported study strengths and weaknesses
Study description+774 characters
Patients with a primary diagnosis of soft tissue sarcoma of the lower extremities undergoing treatment with neo-adjuvant radiation therapy and surgical resection will be screened for eligibility. All participants will receive pre-operative radiation treatment per standard of care and will undergo su [...]
Study sites1 entry, revised
DUkeDuke University
Study title-90 characters
Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management offor Soft Tissue Sarcoma WithPilot Neo-Adjuvant Radiation and Surgical ResectionStudy
2021-12-29
Study Status, Study Design v6
Primary completion date2024-12→2024-12-31
Completion date2024-12→2024-12-31
Enrollment target180→20
Show 5 earlier versions
2021-01-08
Study Status v5
Re-verified, no change to tracked fields
2019-12-20
Study Status v4
Primary completion date2022-12→2024-12
Completion date2022-12→2024-12
2018-10-17
Study Status v3
Re-verified, no change to tracked fields
2017-10-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-09→confirmed 2017-10-19
2017-07-27
Study Status v1
Start date2017-06→2017-09
2017-05-05
Original filing
Duke University
455 trials monitored
See 53 trials at risk
Sarcoma
947 trials monitored
See 53 trials at risk
A parallel-group randomized pilot trial at a single institution (Duke University) on the effect of postoperative hyperbaric oxygen therapy on wound healing in patients with soft tissue sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.. Participants will be allocated to either the treatment group (HBOT) or control (standard of care) by computer-generated randomization, stratified by tumor size (≤10cm and \>10cm). An unequal randomization of 2:1 will be utilized to provide experience prescribing HBOT to more patients.
Trial Details
NCT Number NCT03144206
Lead Sponsor Duke University
Conditions Sarcoma, Hyperbaric Oxygen Therapy
Enrollment 20 participants
Start Date 2017-10-19
Primary Completion 2026-07-12 (estimated)
Study Completion 2026-07-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-27