Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01998932
Other study ID # 13HH0574
Secondary ID 15384
Status Completed
Phase N/A
First received November 25, 2013
Last updated June 29, 2015
Start date November 2013
Est. completion date June 2015

Study information

Verified date June 2015
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female over the age of 18 years

- Chronic venous ulceration - Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85.

- Ulceration present for at least four weeks.

- Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.

Exclusion Criteria:

- Acute infection in the studied lower limb within the last four weeks

- History of malignancy in the lower limb to be studied

- History of connective tissue disease

- Patients on medications that can cause immunosuppression - Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Imperial College Healthcare NHS Trust - Charing Cross Hospital London

Sponsors (3)

Lead Sponsor Collaborator
Imperial College London Cambridge University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biological profile of healing venous ulcers versus non-healing venous ulcers Repeated assays at weeks 0, 1, 2, 4, 8, 12 and 20. Markers of wound healing and metabonomic assays. Ulcers will be stratified into healing and non healing and differences in the biological profiles will be determined using multivariate statistical analysis. 20 weeks No
Secondary Differential biological response in non healing ulcers treated with a biological dressing. 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. 8 weeks No
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
Withdrawn NCT00648674 - A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Phase 4
Terminated NCT00727701 - Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development Phase 1
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