Clinical Trials Logo
  1. Home
  2. Varicose Ulcer
  3. NCT01998932

Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb — MOJITO  

Varicose Ulcer Clinical Trial

Official title:
Clinical Study to Identify Biological Markers to Predict Wound Healing in Patients With Chronic Venous Ulceration of the Lower Limb

Clinical Trial Summary

Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.

However, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. The standard treatment of this condition in the United Kingdom is to undertaken compression bandaging of the lower limb.

In order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile.

This work may provide insights into predicting who will respond to treatment and targets for treatment in the future.

Clinical Trial Description

Forty patients with chronic venous ulceration of the lower limb who meet the inclusion criteria will be entered into the study and assessed over a twenty week period with assessments at week 0, 1, 2, 4, 8, 12 and 20. Urine, serum and ulcer fluid will be sampled.

If the ulcer has not healed, further assessments using an approved biological dressing will be undertaken at weeks 20, 21, 22, 23, 25 and 28 with further sampling of ulcer fluid, urine and serum.

Samples will undergo metabolic profiling using established metabonomic techniques developed at Imperial College. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01998932
Study type Observational
Source Imperial College London
Contact
Status Completed
Phase N/A
Start date November 2013
Completion date June 2015
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT02561013 - A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers N/A
Recruiting NCT05364112 - Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency N/A
Completed NCT00656383 - Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population N/A
Active, not recruiting NCT02973893 - Study of VF001-DP in Patients With Chronic Venous Leg Ulcers Phase 2
Not yet recruiting NCT02873728 - Remote Ischemic Conditioning for Treatment of Chronic Wounds N/A
Recruiting NCT06135246 - Laser Therapy for Venous Leg Ulcers N/A
Active, not recruiting NCT03744858 - The Role of Pyroptosis in Chronic Venous Disease
Completed NCT01449422 - Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers. Phase 4
Completed NCT00838500 - THERMES ET VEINES: Spa for Prevention of Leg Ulcers Phase 3
Completed NCT04039789 - Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care. N/A
Completed NCT04280679 - Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU N/A
Completed NCT02512159 - Skin Ulcers Treatment With an Handicraft Topical Device Phase 4
Completed NCT02896725 - Wool-derived Keratin Dressings for Venous Leg Ulcers N/A
Completed NCT04310280 - Effects of Local Insulin on Varicose Ulcers for Wound Healing Phase 3
Completed NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence Phase 2
Recruiting NCT03127904 - Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial N/A
Terminated NCT00727701 - Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development Phase 1
Withdrawn NCT00648674 - A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Phase 4
Completed NCT00399308 - Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers Phase 1/Phase 2
Completed NCT00426972 - Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites Phase 3