Copper Impact on Venous Insufficiency and Lipodermatosclerosis

NCT03283800 | Completed

• 1 other identifier: 15/04
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Venous disease has an adverse impact on the quality of life of patients and the NHS spends considerable resources on this chronic condition. Copper has been shown to promote new blood vessel formation and therefore improve blood supply to the affected area and possibly skin conditions. Copper has also been shown to have strong antimicrobial properties. We plan to perform a study whereby patients who would normally be given leg stockings will be asked to wear similar stockings except that one of the stockings will contain copper fibers. Neither the patient nor the clinician will know which is which. Photographs of the leg conditions will be taken at baseline, 2, 4 and 8 weeks to evaluate healing. Benefit will be evaluated by a symptom questionnaire, severity scoring tools and healing scores taken from the serial photographs.

Conditions

Lipodermatosclerosis; Chronic Venous Insufficiency; Venous Insufficiency; Varicose Veins

Keywords

Copper Oxide; Compression Therapy; Chronic Venous Disease; Randomised Controlled Trial; Lipodermatosclerosis

Outcome Measures

Primary Outcomes (2)

• Aberdeen Varicose Vein Questionnaire (AVVQ)

  Validated questionnaire consisting of 13 questions on signs and symptoms of chronic venous insufficiency for each leg seperately and questions on compression stocking usage and quality of life. The scoring of the questionnaire is from 0, which indicates no effect on the patient, to 100, which indicates a severe effect.

  2 weeks

• Venous Clinical Severity Scoring (VCSS)

  Assessment tool consisting of 10 items: pain, varicose veins, oedema, skin pigmentation, inflammation, induration, ulceration (number, size and duration) and use of compression therapy, which are scored on a severity scale from 0 to 3.

  24 hours

Secondary Outcomes (1)

• Lipodermatosclerosis surface area

  2, 4 and 8 weeks after wearing compression stockings

Study Arms (2)

Copper impregnated compression stocking

EXPERIMENTAL

Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.

Other: Copper impregnated compression stocking

Normal compression stocking

PLACEBO COMPARATOR

Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks

Other: Normal compression stocking

Interventions

Copper impregnated compression stocking OTHER

Copper impregnated compression stocking

Copper impregnated compression stocking

Normal compression stocking OTHER

Normal compression stocking without copper

Normal compression stocking

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• CEAP classification 4 in both legs
• Venous disease confirmed by venous duplex
• Ability to understand and read the patient information sheet (in English)
• Ability to give informed consent

You may not qualify if:

• Inability to give consent
• Pregnancy
• Current ulceration
• Wilson's disease
• Allergy to copper
• Arterial insufficiency of the lower extremities

Sponsors & Collaborators

• Croydon Health Services NHS Trust: lead

Related Publications (16)

• Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.

  PMID: 22466974 BACKGROUND

• Van den Oever R, Hepp B, Debbaut B, Simon I. Socio-economic impact of chronic venous insufficiency. An underestimated public health problem. Int Angiol. 1998 Sep;17(3):161-7.

  PMID: 9821029 BACKGROUND

• Motykie GD, Caprini JA, Arcelus JI, Reyna JJ, Overom E, Mokhtee D. Evaluation of therapeutic compression stockings in the treatment of chronic venous insufficiency. Dermatol Surg. 1999 Feb;25(2):116-20. doi: 10.1046/j.1524-4725.1999.08095.x.

  PMID: 10037516 BACKGROUND

• Eklof B, Perrin M, Delis KT, Rutherford RB, Gloviczki P; American Venous Forum; European Venous Forum; International Union of Phlebology; American College of Phlebology; International Union of Angiology. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009 Feb;49(2):498-501. doi: 10.1016/j.jvs.2008.09.014.

  PMID: 19216970 BACKGROUND

• Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014.

  PMID: 17980798 BACKGROUND

• Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.

  PMID: 16101497 BACKGROUND

• O'Gorman J, Humphreys H. Application of copper to prevent and control infection. Where are we now? J Hosp Infect. 2012 Aug;81(4):217-23. doi: 10.1016/j.jhin.2012.05.009. Epub 2012 Jun 26.

  PMID: 22738611 BACKGROUND

• Borkow G, Gabbay J, Zatcoff RC. Could chronic wounds not heal due to too low local copper levels? Med Hypotheses. 2008;70(3):610-3. doi: 10.1016/j.mehy.2007.06.006. Epub 2007 Aug 6.

  PMID: 17689198 BACKGROUND

• Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.

  PMID: 11959648 BACKGROUND

• Tenaud I, Sainte-Marie I, Jumbou O, Litoux P, Dreno B. In vitro modulation of keratinocyte wound healing integrins by zinc, copper and manganese. Br J Dermatol. 1999 Jan;140(1):26-34. doi: 10.1046/j.1365-2133.1999.02603.x.

  PMID: 10215764 BACKGROUND

• Ahmed Z, Briden A, Hall S, Brown RA. Stabilisation of cables of fibronectin with micromolar concentrations of copper: in vitro cell substrate properties. Biomaterials. 2004 Feb;25(5):803-12. doi: 10.1016/s0142-9612(03)00596-9.

  PMID: 14609669 BACKGROUND

• Uauy R, Olivares M, Gonzalez M. Essentiality of copper in humans. Am J Clin Nutr. 1998 May;67(5 Suppl):952S-959S. doi: 10.1093/ajcn/67.5.952S.

  PMID: 9587135 BACKGROUND

• Hostynek JJ, Dreher F, Maibach HI. Human skin penetration of a copper tripeptide in vitro as a function of skin layer. Inflamm Res. 2011 Jan;60(1):79-86. doi: 10.1007/s00011-010-0238-9. Epub 2010 Aug 20.

  PMID: 20721598 BACKGROUND

• Weinberg, I., Lazary, A., Jefidoff, A., Vatine, J.J., Borkow, G., Ohana, N. Safety of using diapers containing copper oxide in chronic care elderly patients. Open Biol J. 2013;6:54-59.

  BACKGROUND

• Borkow G, Okon-Levy N, Gabbay J. Copper oxide impregnated wound dressing: biocidal and safety studies. Wounds. 2010 Dec;22(12):301-10.

  PMID: 25901580 BACKGROUND

• Arendsen LP, Vig S, Thakar R, Sultan AH. Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial. Phlebology. 2019 May;34(4):224-230. doi: 10.1177/0268355518795329. Epub 2018 Aug 27.

  PMID: 30149775 DERIVED

MeSH Terms

Conditions

Lipodermatosclerosis; Venous Insufficiency; Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Abdul H Sultan

  Croydon Health Services NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All stockings are marked with an 'L' for the left or 'R' for the right foot. The manufacturer has randomly marked the copper stockings with an 'L' or 'R' and paired these with a non-copper stocking. A closed envelope will contain the unique numbers of all the pairs of stockings and the information on which stocking contains the copper. This envelope will remain closed for the whole recruitment period and throughout analysis of the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Gynaecologist

Model Details: All participants will be asked to wear compression stockings. One of the pair will have copper oxide ions permanently attached to the nylon fibres and these stockings will contain 2-3% copper ions. The participants will wear a copper stocking on one leg (study leg) and a non-copper stocking on the other (control leg).

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: September 23, 2015
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share