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| Sponsored by: |
Renovo |
|---|---|
| Information provided by: | Renovo |
| ClinicalTrials.gov Identifier: | NCT00426972 |
Purpose
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Burn Trauma Varicose Ulcer |
Drug: estradiol (Zesteem) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites. |
| Estimated Enrollment: | 148 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | October 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Klinik fur Dermatologie und Allergologie, Bochum St Josef Hospital | |
| Bochum, Germany, D-44791 | |
| Klinik fur Plastiche-Asthetische- u. Handchiurgie. Kinikum Offenbach | |
| Offenbach, Germany, D-63069 | |
| Klinikum St. Georg- Leipzig | |
| Leipzig, Germany, D-04129 | |
| HSK, Wilhelm Fresenius Klinik | |
| Wiesbaden, Germany, 65191 | |
| Zentrum der Dermatologie und Venerologie, Johann Wolfgang Institut | |
| Frankfurt, Germany, D-D-60590 | |
| Universitatsklinik fur Plastiche Chirurgie und Schwerbrandverletze | |
| Bochum, Germany, D-44789 | |
| Universitatsklinikum Freiburg | |
| Freiburg, Germany, D-79106 | |
| Klinik fur Plastiche- Hand und Wiederherstellungschirurgie | |
| Hannover, Germany, 30625 | |
| Abteilung fur Plastiche und Handchirurgie | |
| Erlangen, Germany, 12, 91054 | |
| Universitatsklinikum Aachen Klinik fur Plastiche Chirurgie | |
| Aachen, Germany, 52074 | |
| Carl- Thiem- klinikum Cottbus | |
| Cottbus, Germany, 03048 | |
| Otto-von-Gericke Universitat Magdeburg, universitatsklinikum fur Dermatologie und Venerologie | |
| Magdeburg, Germany, 39120 | |
| Klinik fur Dermatologie, Friedrich-Schiller Universitat Jena | |
| Jena, Germany, 07740 | |
| Klinikum Koln-Merheim Abteilung Plastiche-, Rekonstruktive-, Asthetische- Hand- Verbrennungschirurgie | |
| Koln, Germany, 51109 | |
| Latvia | |
| P Stradins Clinical University Hospital | |
| Riga, Latvia, LV1002 | |
| Russian Federation | |
| The Central Clinical Hospital # 1 of LLC "Russian Railways" | |
| Moscow, Russian Federation, 125367 | |
| Russian Medical Academy for Postgraduate Education, Surgery | |
| Moscow, Russian Federation, 113093 | |
| City Clinical Hospital # 36 | |
| Moscow, Russian Federation, 105187 | |
| City Clinical Hospital # 36 | |
| Moscow, Russian Federation, 111539 | |
| Research Institute for Traumatology and Orthopaedy, Verhne-Volzhskaya Naberezhnaya | |
| Novorogod, Russian Federation | |
| City Clinical Hospital # 7 | |
| Saratov, Russian Federation, 410005 | |
| Clinical Hospital n.a. N.V. Solovyov | |
| Yaroslavl, Russian Federation | |
| Regional Clinical Hospital, Partizana | |
| Krasnoyarsk, Russian Federation, 660022 | |
| City Clinical Hospital #13 | |
| Moscow, Russian Federation, 115280 | |
| United Kingdom | |
| Wythenshawe Hospital | |
| Manchester, United Kingdom, M23 9LT | |
| Selly Oak Hospital | |
| Birmingham, United Kingdom, B29 6JD | |
| Broomfield Hospital | |
| Chelmsford, United Kingdom, CM1 7ET | |
| United Kingdom, Buckinghamshire | |
| Stoke Mandeville Hospital | |
| Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL | |
| United Kingdom, Wakefield | |
| Pinderfields Hospital | |
| Aberford Road, Wakefield, United Kingdom, WF1 4DG | |
| United Kingdom, West Sussex | |
| McIndoe Burns Unit, Queen Victoria Hospital | |
| East Grinstead, West Sussex, United Kingdom, RH19 3DZ | |
| Principal Investigator: | Ken Dunn, MD | Wythenshawe Hospital |
More Information
| Study ID Numbers: | RN1002-0066 |
| Study First Received: | January 24, 2007 |
| Last Updated: | October 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00426972 History of Changes |
| Health Authority: | Latvia: State Agency of Medicines |
|
Burns Estrogens Skin Diseases Contraceptive Agents Benzoates Hormone Antagonists Ulcer Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries |
Vascular Diseases Estradiol 17 beta-cypionate Hormones Estradiol Varicose Ulcer Varicose Veins Estradiol 3-benzoate Polyestradiol phosphate Skin Ulcer Leg Ulcer |
|
Estrogens Skin Diseases Contraceptive Agents Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Reproductive Control Agents Estradiol 17 beta-cypionate Hormones |
Pharmacologic Actions Estradiol Varicose Ulcer Varicose Veins Therapeutic Uses Estradiol 3-benzoate Cardiovascular Diseases Skin Ulcer Polyestradiol phosphate Leg Ulcer |