Trial Outcomes & Findings for Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU) (NCT NCT04696354)

Last Updated: 2024-10-01

Results Overview

Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group at 3 months. Complete ulcer healing is defined by 100% epithelialization of the venous ulcer. Healing will not be assumed for any area of the wound where a scab is present.

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2024-10-01

Participant Flow

No analysis performed. Study was terminated due to slow enrollment. Only 12 enrollments of the required 266 subjects.

For the small number of enrolled patients no data was collected for analysis. No outcome measures to report.

Participant milestones

Participant milestones
Measure	Interrogation Arm patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement. IVUS: Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.	Deferred Interrogation Arm Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow: * Periodic leg elevation. * Sclerotherapy under ulcer bed. * Recommend mechanical debridement as needed. * Wound biopsy if evidence of infection. * Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription. * Pain management medication (Pentoxifylline/Trental) allowed but not recommended * Topical antimicrobial as needed. Prohibit: * Negative pressure systems. * Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm. Continued Compression Therapy/Stockings: Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
Overall Study STARTED	6	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Interrogation Arm patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement. IVUS: Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.	Deferred Interrogation Arm Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow: * Periodic leg elevation. * Sclerotherapy under ulcer bed. * Recommend mechanical debridement as needed. * Wound biopsy if evidence of infection. * Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription. * Pain management medication (Pentoxifylline/Trental) allowed but not recommended * Topical antimicrobial as needed. Prohibit: * Negative pressure systems. * Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm. Continued Compression Therapy/Stockings: Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
Overall Study Study termination	6	6

Baseline Characteristics

No statistical analysis was performed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interrogation Arm n=6 Participants patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement. IVUS: Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.	Deferred Interrogation Arm n=6 Participants Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow: * Periodic leg elevation. * Sclerotherapy under ulcer bed. * Recommend mechanical debridement as needed. * Wound biopsy if evidence of infection. * Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription. * Pain management medication (Pentoxifylline/Trental) allowed but not recommended * Topical antimicrobial as needed. Prohibit: * Negative pressure systems. * Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm. Continued Compression Therapy/Stockings: Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.	Total n=12 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants No statistical analysis was performed.	0 Participants No statistical analysis was performed.	0 Participants No statistical analysis was performed.
Sex: Female, Male Male	0 Participants No statistical analysis was performed.	0 Participants No statistical analysis was performed.	0 Participants No statistical analysis was performed.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) Asian	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) Black or African American	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) White	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) More than one race	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Race (NIH/OMB) Unknown or Not Reported	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed	0 Participants No statistical analysis was performed
Region of Enrollment United States	2 participants n=6 Participants	1 participants n=6 Participants	3 participants n=12 Participants
Region of Enrollment United Kingdom	4 participants n=6 Participants	4 participants n=6 Participants	8 participants n=12 Participants
Region of Enrollment France	1 participants n=6 Participants	0 participants n=6 Participants	1 participants n=12 Participants

PRIMARY outcome

Timeframe: 3 months

Population: No data was collected for analysis. No outcome data to report.

Outcome measures

Outcome data not reported

Adverse Events

Interrogation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deferred Interrogation Arm

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

Danielle Op den Kamp, Sr Manager Clinical Operations

Philips

Phone: +31 (0)627218737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place