Trial Outcomes & Findings for Topical Oxygen Therapy for Diabetic Wounds (NCT NCT02313428)

NCT ID: NCT02313428

Last Updated: 2024-04-25

Results Overview

Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: baseline and 16 weeks
• Results posted on: 2024-04-25

Participant Flow

Participant milestones

Measure	Standard of Care With Topical Oxygen Treatment patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only patients that have a chronic wound will receive only their standard of care treatment.
Overall Study STARTED	2	2
Overall Study Completing 16 wk Visit	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Standard of Care With Topical Oxygen Treatment patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only patients that have a chronic wound will receive only their standard of care treatment.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Topical Oxygen Therapy for Diabetic Wounds

Baseline characteristics by cohort

Measure	Standard of Care With Topical Oxygen Treatment n=1 Participants patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only n=1 Participants patients that have a chronic wound will receive only their standard of care treatment.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44 years n=5 Participants	63 years n=7 Participants	53.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 16 weeks

Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care

Outcome measures

Measure	Standard of Care With Topical Oxygen Treatment n=1 Participants patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only n=1 Participants patients that have a chronic wound will receive only their standard of care treatment.
Change in Wound Closure	3.3 cm2 Interval 3.3 to 3.3	0.00 cm2 Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 16 weeks

Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care

Outcome measures

Measure	Standard of Care With Topical Oxygen Treatment n=1 Participants patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only n=1 Participants patients that have a chronic wound will receive only their standard of care treatment.
Rate of Amputations	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care

Outcome measures

Measure	Standard of Care With Topical Oxygen Treatment n=1 Participants patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only n=1 Participants patients that have a chronic wound will receive only their standard of care treatment.
Complication Rate	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: no data could be collected on the cost of measure

Post-test health expenditures at 16 weeks of Topical Oxygen Therapy or Standard of Care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care. A cumulative score was calculated based on the QoL responses:

Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.

Outcome measures

Measure	Standard of Care With Topical Oxygen Treatment n=1 Participants patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities). Topical Oxygen Chamber for Extremities: Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers	Standard of Care Only n=1 Participants patients that have a chronic wound will receive only their standard of care treatment.
Quality of Life for Subjects- SF-36	38.9 percent of total response	51.5 percent of total response

Adverse Events

Standard of Care With Topical Oxygen Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Only

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

Sashwati Roy

University of Pittsburgh

Phone: 412-648-8297

Email: sar543@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place