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CompletedNCT00435773Updated Apr 9, 2007

Leeches for the Treatment of Knee Osteoarthritis

A Phase 2 interventional study of Single Leeching and Repeated Leeching after 4 weeks in Osteoarthritis and Arthralgia, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2007-04-09.

Sponsored by RWTH Aachen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
118
Allocation
Randomized
Sex
All
01

Study summary

Previous studies have not addressed the question, whether or not a repeated leeching can supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a randomized study to the effectiveness of single and repeated leech therapy in cases with advanced osteoarthritis of the knee using a large patient group compared to a control group, who were both blinded to the actual treatment modality.

02

Conditions studied

  • Osteoarthritis
  • Arthralgia

Keywords

  • Osteoarthritis
  • Leeching
  • Randomized Controlled Trial
  • Arthralgia
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 118 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Osteoarthritis of the knee
  • Persistent osteoarthritic symptoms for at least 6 months
  • Radiographic evidence of late stage osteoarthritis of the knee (stage III-IV)
  • History of conservative management including pain medication and physical therapy

Exclusion criteria

Exclusion Criteria:

  • Anticoagulant treatment or history of hemophilia
  • History or presence of rheumatic diseases leading to secondary osteoarthritis
  • Presence of hematological, hepatic, renal or immunological disease
  • Insulin-dependant diabetes mellitus
  • Intraarticular injections or systemic application of corticosteroids during the 3 preceding months
  • History of surgery of the affected knee during the last 3 months or joint replacement
  • History of previous leech therapy
  • Lack of informed consent
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
118 participants

Interventions

  • ProcedureSingle Leeching
  • ProcedureRepeated Leeching after 4 weeks
  • ProcedurePlacebo Leeching
06

What researchers measure

Primary outcomes

  1. KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

  2. WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

  3. VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months

Secondary outcomes

  1. KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months

  2. WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months

  3. Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months

  4. Adverse events

07

Study locations

1 site
  • Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
    Aachen, 52074, Germany
08

References and documents

Publications

  • Hyson JM. Leech therapy: a history. J Hist Dent. 2005 Mar;53(1):25-7. PubMed 15926663 ↗
  • Whitaker IS, Izadi D, Oliver DW, Monteath G, Butler PE. Hirudo Medicinalis and the plastic surgeon. Br J Plast Surg. 2004 Jun;57(4):348-53. doi: 10.1016/j.bjps.2003.12.016. PubMed 15145739 ↗
  • Rao J, Whitaker IS. Use of Hirudo medicinalis by maxillofacial surgical units in the United Kingdom: current views and practice. Br J Oral Maxillofac Surg. 2003 Feb;41(1):54-5. doi: 10.1016/s0266-4356(02)00284-x. No abstract available. PubMed 12576043 ↗
  • Weinfeld AB, Yuksel E, Boutros S, Gura DH, Akyurek M, Friedman JD. Clinical and scientific considerations in leech therapy for the management of acute venous congestion: an updated review. Ann Plast Surg. 2000 Aug;45(2):207-12. doi: 10.1097/00000637-200045020-00021. PubMed 10949353 ↗
  • Dabb RW, Malone JM, Leverett LC. The use of medicinal leeches in the salvage of flaps with venous congestion. Ann Plast Surg. 1992 Sep;29(3):250-6. doi: 10.1097/00000637-199209000-00010. PubMed 1524375 ↗
  • Hayden RE, Phillips JG, McLear PW. Leeches. Objective monitoring of altered perfusion in congested flaps. Arch Otolaryngol Head Neck Surg. 1988 Dec;114(12):1395-9. doi: 10.1001/archotol.1988.01860240045021. PubMed 3190866 ↗
  • Hernandez-Diaz S, Varas-Lorenzo C, Garcia Rodriguez LA. Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):266-74. doi: 10.1111/j.1742-7843.2006.pto_302.x. PubMed 16611201 ↗
  • Hernandez-Diaz S, Garcia-Rodriguez LA. Epidemiologic assessment of the safety of conventional nonsteroidal anti-inflammatory drugs. Am J Med. 2001 Feb 19;110 Suppl 3A:20S-7S. doi: 10.1016/s0002-9343(00)00682-3. PubMed 11173046 ↗
  • Pilcher H. Medicinal leeches: stuck on you. Nature. 2004 Nov 4;432(7013):10-1. doi: 10.1038/432010a. No abstract available. PubMed 15525954 ↗
  • Michalsen A, Moebus S, Spahn G, Esch T, Langhorst J, Dobos GJ. Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study. Altern Ther Health Med. 2002 Sep-Oct;8(5):84-8. PubMed 12233807 ↗
  • Michalsen A, Klotz S, Ludtke R, Moebus S, Spahn G, Dobos GJ. Effectiveness of leech therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2003 Nov 4;139(9):724-30. doi: 10.7326/0003-4819-139-9-200311040-00006. PubMed 14597456 ↗
  • Hochberg MC. Multidisciplinary integrative approach to treating knee pain in patients with osteoarthritis. Ann Intern Med. 2003 Nov 4;139(9):781-3. doi: 10.7326/0003-4819-139-9-200311040-00013. No abstract available. PubMed 14597463 ↗
  • Guyatt GH, Sackett DL, Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993 Dec 1;270(21):2598-601. doi: 10.1001/jama.270.21.2598. No abstract available. PubMed 8230645 ↗
  • Wolfe F, Lane NE. The longterm outcome of osteoarthritis: rates and predictors of joint space narrowing in symptomatic patients with knee osteoarthritis. J Rheumatol. 2002 Jan;29(1):139-46. PubMed 11824950 ↗
  • Hochberg MC, Altman RD, Brandt KD, Moskowitz RW. Design and conduct of clinical trials in osteoarthritis: preliminary recommendations from a task force of the Osteoarthritis Research Society. J Rheumatol. 1997 Apr;24(4):792-4. PubMed 9101520 ↗
  • Altman R, Brandt K, Hochberg M, Moskowitz R, Bellamy N, Bloch DA, Buckwalter J, Dougados M, Ehrlich G, Lequesne M, Lohmander S, Murphy WA Jr, Rosario-Jansen T, Schwartz B, Trippel S. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage. 1996 Dec;4(4):217-43. doi: 10.1016/s1063-4584(05)80101-3. No abstract available. PubMed 11048620 ↗
  • Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88. PubMed 9699158 ↗
  • Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562. PubMed 10503556 ↗
  • Whitaker IS, Rao J, Izadi D, Butler PE. Historical Article: Hirudo medicinalis: ancient origins of, and trends in the use of medicinal leeches throughout history. Br J Oral Maxillofac Surg. 2004 Apr;42(2):133-7. doi: 10.1016/S0266-4356(03)00242-0. PubMed 15013545 ↗
  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. PubMed 3068365 ↗
  • Lahav A, Burks RT, Greis PE, Chapman AW, Ford GM, Fink BP. Clinical outcomes following osteochondral autologous transplantation (OATS). J Knee Surg. 2006 Jul;19(3):169-73. doi: 10.1055/s-0030-1248101. PubMed 16893154 ↗
  • Englund M, Lohmander LS. Patellofemoral osteoarthritis coexistent with tibiofemoral osteoarthritis in a meniscectomy population. Ann Rheum Dis. 2005 Dec;64(12):1721-6. doi: 10.1136/ard.2005.035568. Epub 2005 Apr 20. PubMed 15843446 ↗
  • Kessler S, Lang S, Puhl W, Stove J. [The Knee Injury and Osteoarthritis Outcome Score--a multifunctional questionnaire to measure outcome in knee arthroplasty]. Z Orthop Ihre Grenzgeb. 2003 May-Jun;141(3):277-82. doi: 10.1055/s-2003-40083. German. PubMed 12822074 ↗
  • Markwardt F, Hauptmann J, Nowak G, Klessen C, Walsmann P. Pharmacological studies on the antithrombotic action of hirudin in experimental animals. Thromb Haemost. 1982 Jun 28;47(3):226-9. PubMed 7112494 ↗
  • Brown JE, Baugh RF, Hougie C. The inhibition of the intrinsic generation of activated factor X by heparin and hirudin. Thromb Res. 1980 Jan 1-15;17(1-2):267-72. doi: 10.1016/0049-3848(80)90314-x. No abstract available. PubMed 7376133 ↗
  • Dippenaar R, Smith J, Goussard P, Walters E. Meningococcal purpura fulminans treated with medicinal leeches. Pediatr Crit Care Med. 2006 Sep;7(5):476-8. doi: 10.1097/01.PCC.0000235422.23812.B4. PubMed 16878049 ↗
  • Ascenzi P, Amiconi G, Bode W, Bolognesi M, Coletta M, Menegatti E. Proteinase inhibitors from the European medicinal leech Hirudo medicinalis: structural, functional and biomedical aspects. Mol Aspects Med. 1995;16(3):215-313. doi: 10.1016/0098-2997(95)00002-x. No abstract available. PubMed 8569452 ↗
  • Rigbi M, Levy H, Eldor A, Iraqi F, Teitelbaum M, Orevi M, Horovitz A, Galun R. The saliva of the medicinal leech Hirudo medicinalis--II. Inhibition of platelet aggregation and of leukocyte activity and examination of reputed anaesthetic effects. Comp Biochem Physiol C Comp Pharmacol Toxicol. 1987;88(1):95-8. doi: 10.1016/0742-8413(87)90052-1. PubMed 2890494 ↗
  • Scott K. Is hirudin a potential therapeutic agent for arthritis? Ann Rheum Dis. 2002 Jun;61(6):561-2. doi: 10.1136/ard.61.6.561. No abstract available. PubMed 12006337 ↗
  • Bush D, Fritz H, Knight C, Mount J, Scott K. A hirudin-sensitive, growth-related proteinase from human fibroblasts. Biol Chem. 1998 Feb;379(2):225-9. doi: 10.1515/bchm.1998.379.2.225. PubMed 9524076 ↗
  • de Chalain TM. Exploring the use of the medicinal leech: a clinical risk-benefit analysis. J Reconstr Microsurg. 1996 Apr;12(3):165-72. doi: 10.1055/s-2007-1006471. PubMed 8726336 ↗
  • Lineaweaver WC, Hill MK, Buncke GM, Follansbee S, Buncke HJ, Wong RK, Manders EK, Grotting JC, Anthony J, Mathes SJ. Aeromonas hydrophila infections following use of medicinal leeches in replantation and flap surgery. Ann Plast Surg. 1992 Sep;29(3):238-44. doi: 10.1097/00000637-199209000-00008. PubMed 1524373 ↗
  • Fenollar F, Fournier PE, Legre R. Unusual case of Aeromonas sobria cellulitis associated with the use of leeches. Eur J Clin Microbiol Infect Dis. 1999 Jan;18(1):72-3. doi: 10.1007/s100960050232. No abstract available. PubMed 10192721 ↗
  • Ikizceli I, Avsarogullari L, Sozuer E, Yurumez Y, Akdur O. Bleeding due to a medicinal leech bite. Emerg Med J. 2005 Jun;22(6):458-60. doi: 10.1136/emj.2003.013847. PubMed 15911965 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00435773
Lead sponsor
RWTH Aachen University
Collaborators
University Hospital, Aachen
First posted
Feb 15, 2007
Start date
Feb 2004
Completion
Dec 2004
Last update
Apr 9, 2007

Study contacts

Stefan Andereya, MD
study chair · Department of Orthopaedic Surgery, University Hospital of the RWTH Aachen, Germany
View the source record on ClinicalTrials.gov ↗

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