NCT03283800: CIVIL

Copper Impact on Venous Insufficiency and Lipodermatosclerosis

Completed NA Last updated 15 September 2017

What this trial tests

NA trial testing Copper impregnated compression stocking in Lipodermatosclerosis in 16 participants. Completed in 9 January 2017.

Timeline

23 September 2015

Primary endpoint
9 January 2017

9 January 2017

Quick facts

Lead sponsor	Croydon Health Services NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	16
Start date	23 September 2015
Primary completion	9 January 2017
Estimated completion	9 January 2017

Drugs / interventions tested

• Copper impregnated compression stocking
• Normal compression stocking

Conditions studied

• Lipodermatosclerosis — all drugs for Lipodermatosclerosis →
• Chronic Venous Insufficiency — all drugs for Chronic Venous Insufficiency →
• Venous Insufficiency — all drugs for Venous Insufficiency →
• Varicose Veins — all drugs for Varicose Veins →

Sponsor

Croydon Health Services NHS Trust

Who can join

Eligibility, any sex, with Lipodermatosclerosis or Chronic Venous Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Copper Homeostasis in Brain Disease.
   An Y, Li S, Huang X, Chen X, et al · · 2022 · cited 108× · PMID 36430330 · DOI 10.3390/ijms232213850
2. Upcoming treatments for morphea.
   Wenzel D, Haddadi NS, Afshari K, Richmond JM, et al · · 2021 · cited 20× · PMID 34272836 · DOI 10.1002/iid3.475
3. Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial.
   Arendsen LP, Vig S, Thakar R, Sultan AH. · · 2019 · cited 9× · PMID 30149775 · DOI 10.1177/0268355518795329