Trial Outcomes & Findings for Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb (NCT NCT01998932)

Results Overview

The primary outcome was biomarker identification via nuclear magnetic resonance spectroscopy and mass spectrometry. Outcome measure units - number of biomarkers predictive of ulcer healing.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

20 weeks

Results posted on

2024-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Venous Ulcer Patients with a chronic venous ulcer defined as a wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 and a colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Venous Ulcer n=28 Participants Patients with a chronic venous ulcer defined as a wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 and a colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.
Age, Categorical <=18 years	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=28 Participants
Age, Categorical >=65 years	22 Participants n=28 Participants
Age, Continuous	71 years n=28 Participants
Sex: Female, Male Female	10 Participants n=28 Participants
Sex: Female, Male Male	18 Participants n=28 Participants
Region of Enrollment United Kingdom	28 participants n=28 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: Data from all participants was analysed, subgrouped by participants who healed and those who did not heal

The primary outcome was biomarker identification via nuclear magnetic resonance spectroscopy and mass spectrometry. Outcome measure units - number of biomarkers predictive of ulcer healing.

Outcome measures

Outcome measures
Measure	Chronic Venous Ulcer n=28 Participants Patients with a chronic venous ulcer defined as a wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 and a colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.
Identification of Biomarkers Predictive of Ulcer Healing.	9 Number of biomarkers

SECONDARY outcome

Timeframe: 8 weeks

Population: This part of the study was not performed

Non healing ulcers at twenty weeks will be treated in addition to standard dressing with a biological augmented dressing approved for use in the UK. This will determine if an alternative biological profile can be obtained representing a 'healing' response.

Outcome measures

Outcome data not reported

Adverse Events

Chronic Venous Ulcer

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

Miss Sarah Onida

Imperial College London

Phone: : +44 (0) 20 3311 7335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place