Therapeutic Effectiveness of Irsal-i-Alaq (Hirudotherapy) for Venous Ulcer Treatment: A Clinical Case Study

Introduction:

Venous ulcerations represent chronic, non-healing wounds of the lower extremities that constitute a prevalent clinical manifestation of chronic venous insufficiency. In the absence of appropriate therapeutic intervention, these ulcerative lesions may precipitate severe complications, including secondary bacterial infections and compromised patient mobility [1]. Venous leg ulcers (VLUs) function as late-stage clinical indicators of chronic venous insufficiency (CVI) and venous hypertension. Under normal physiological conditions, calf muscle pump mechanisms and competent intraluminal venous valves facilitate antegrade venous flow while preventing retrograde blood circulation. However, when venous reflux, vascular obstruction, or combined pathophysiology develops, chronic venous hypertension initiates the cascade of dermatological and vascular complications culminating in VLU formation (See Image. Venous Leg Ulcer) [2].

The three principal categories of lower extremity ulcerative pathology comprise venous, arterial, and neuropathic etiologies. Venous ulcerations constitute the majority of lower extremity ulcerative conditions, whereas pedal ulcerations demonstrate greater association with arterial insufficiency or neuropathic pathophysiology¹. Venous disease accounts for approximately 80% of lower extremity ulcerations, with arterial pathology contributing 10% to 25%, frequently presenting as coexistent conditions. The incidence of arterial insufficiency demonstrates an anticipated upward trajectory correlating with population aging demographics. Varicose vein prevalence reaches 30% in the general population, with significantly elevated incidence rates observed in geriatric cohorts [3].

Varicose vein distribution demonstrates global prevalence with variations attributed to activity levels and lifestyle determinants. Gender-based epidemiological data reveals higher prevalence rates in females compared to males. The Framingham Study conducted longitudinal surveillance of varicose vein development through biennial assessments over 16 years. Data analysis revealed varicose vein development in 23% and 30% of male and female participants, respectively, during the study period. Venous reflux assessment was not incorporated into the study protocol. The biennial incidence rate for varicose veins measured 39.4 to 51.9 per 1000 population. Peak incidence occurred in females during the fourth decade of life. Ethnic correlations demonstrate significant associations with varicose vein prevalence, with Asian populations exhibiting lower rates of chronic venous insufficiency and varicose veins compared to non-Hispanic white populations [4].

The majority of venous ulcerations localize to the medial malleolar region, with remaining cases distributed across alternative lower extremity and pedal locations. Varicose veins represent the primary clinical manifestation of chronic venous insufficiency, although recently characterized acute lipodermatosclerosis may precede varicosity development. Varicose vein morphology ranges from submalleolar venous flares to progressive degrees of vessel dilatation. Additional progressive manifestations of chronic venous insufficiency include reddish-brown hyperpigmentation and purpura secondary to erythrocyte extravasation into dermal tissue, hemosiderin deposition within macrophages, and melanin accumulation. Eczematous changes characterized by erythema, desquamation, pruritus, and occasional exudation, clinically designated as venous dermatitis, frequently accompany these pathological changes [5].

Historical documentation of varicose veins originates from the Eber’s papyrus circa 1550 BC. Hippocrates established the initial clinical correlation between varicose veins and ulcerative complications. Ancient physicians including Galen, Celsus, Aetius of Aminda, and Pauls Aegien advocated avulsion and cauterization techniques for varicose vein management while implementing compression bandaging for leg ulcer treatment. Medical practitioners from the 10th through 18th centuries attributed lower extremity ulceration to the pathological accumulation of black bile and menstrual blood [6].

Leech saliva contains bioactive compounds demonstrating vasodilatory, anticoagulant, anesthetic, thrombolytic, antimicrobial, analgesic, and anti-inflammatory pharmacological properties. Historical medical applications utilized leeches for localized bloodletting procedures dating to ancient Greek, Roman, and Arabian medical practices. Initial Greek medical literature referenced leech therapy through Themison (80-40 B.C.), a disciple of Asclepiades from the pre-Christian era. Within Indian traditional medicine, H. granulosa species demonstrates established therapeutic efficacy. The pathogenesis of varicose vein symptomatology correlates with the accumulation of pathological humoral substances in lower extremity tissues. Unani medical practitioners have employed bloodletting therapeutic modalities since antiquity for varicose vein prevention and clinical management [7]. Conventional therapeutic approaches frequently incorporate surgical interventions, which may demonstrate variable efficacy and associated procedural complications. In contrast, Unani medical systems provide alternative therapeutic modalities including Irsal-i-Alaq, or Hirudotherapy, involving the clinical application of medicinal leeches to affected anatomical regions⁸. This case study aims to evaluate the clinical efficacy of Irsal-i-Alaq in venous ulcer management.

Case Presentation

A 37-year-old male individual sought medical consultation at the outpatient facility of the Postgraduate Department of Ilaj Bit Tadbeer, Government Unani Medical College, Chennai, India, for evaluation of a persistent venous ulcer affecting the left lower limb. The ulcer demonstrated medial malleolar localization with accompanying clinical features of regional swelling, pain symptomatology, non-suppurative discharge, and hyperpigmented changes in the adjacent dermal tissue. Prior therapeutic management attempts had failed to achieve meaningful clinical resolution.

Intervention

Therapeutic management was implemented through Irsal-i-Alaq, incorporating systematic medicinal leech application with proper SOPs to the affected ulcerative region. The established treatment regimen involved dual leech placement targeting the left medial malleolar area, with biweekly administration frequency during the first 14-day period, followed by weekly therapeutic sessions throughout the subsequent 28-day treatment phase. Comprehensive clinical evaluations were conducted at 7-day intervals to assess treatment efficacy and document key clinical parameters, encompassing wound surface area analysis, healthy granulation tissue presence, epithelialization progress percentage, ulcer depth quantification, pain severity measurement (employing Visual Analog Scale assessment), discharge characterization, olfactory evaluation, and wound enumeration.

Results

Initial clinical assessment revealed ulcer measurements of 4 cm in length, 3 cm in width, and 2 cm in depth. The ulcer base exhibited devitalized granulation tissue with characteristic dark pigmentation, accompanied by absence of epithelialization, exudation, pain symptoms, and olfactory manifestations. Systematic clinical improvement was observed during the 6-week therapeutic course, demonstrating progressive wound size reduction, increased healthy granulation tissue proliferation, and resolution of pain and discharge parameters. Complete ulcer resolution was accomplished at the sixth week endpoint, with total epithelial regeneration of 100%.


Discussion

The successful outcome of this case study suggests that Irsal-i-Alaq may be an effective treatment modality for venous ulcers. Hirudotherapy is believed to exert its therapeutic effects through various mechanisms, including improved blood circulation, reduction of inflammation, and promotion of tissue regeneration [9]. The application of medicinal leeches may facilitate the removal of stagnant blood and toxins from the ulcer site, thereby promoting wound healing. However, further research is needed to elucidate the underlying mechanisms and determine the optimal treatment regimen for venous ulcers [10]. This case exhibited complete healing of the ulcer. In the perspective of venous stasis, the underlying mechanisms of pain involve the activation of nociceptors and the accumulation of algogenic metabolites at the site of the microcirculatory units. Endothelial cells in these areas are particularly sensitive to such metabolites [11].  When a leech attaches to the skin, it engulfs stagnated blood, thereby alleviating mechanical pressure. Additionally, the leech’s salivary secretions, which include anticoagulants, thrombolytics, vasodilators, and anesthetics, are delivered through a pumping action [12]. The anticoagulants and thrombolytics present in leech saliva extend the duration of bleeding, leading to hypovolemic hemodilution, which consequently lowers blood pressure and facilitates the removal of metabolites from the microcirculatory units. Concurrently, the anesthetic agents in the saliva reduce local pain. Furthermore, a reduction in limb girth, indicative of decreased edema, was observed. The biochemical components of leech saliva contribute to the reduction of stasis and blood pooling by prolonging bleeding through their anticoagulant, antithrombotic, and vasodilatory effects [13]. Pigmented lesions observed in stasis dermatitis result from the deposition of hemosiderin in the dermis. Hemosiderin arises from the breakdown of hemoglobin within the cytoplasm of phagocytic cells, which occurs alongside post-inflammatory pigmentation that leads to pigment incontinence. The presence of dermal hemosiderin has a stimulatory effect on melanogenesis, further contributing to the observed pigmentation changes.

Conclusion

These findings suggest that Irsal-i-Alaq represents a therapeutically sound intervention for venous ulcer treatment, as substantiated by the successful clinical resolution observed in this case report. However, large-scale randomized controlled investigations with prolonged observation periods remain imperative to confirm these initial observations and define the clinical positioning of Hirudotherapy within venous ulcer management algorithms. Despite these research requirements, the clinical outcomes presented in this case study emphasize the therapeutic value of Unani medicinal approaches as effective adjunctive interventions for chronic ulcerative conditions, facilitating a comprehensive, multidisciplinary approach to wound healing.

Reference

  • Krizanova O, Penesova A, Hokynkova A, Pokorna A, Samadian A, Babula P. Chronic venous insufficiency and venous leg ulcers: Aetiology, on the pathophysiology‐based treatment. International Wound Journal. 2024 Feb;21(2):e14405.
  • Robles-Tenorio A, Lev-Tov H, Ocampo-Candiani J. Venous Leg Ulcer. [Updated 2022 Sep 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-
  • Shadrina AS, Elgaeva EE, Stanaway IB, Jarvik GP, Namjou B, Wei WQ, Glessner J, Hakonarson H, Suri P, Tsepilov YA. Mendelian randomization analysis of plasma levels of CD209 and MICB proteins and the risk of varicose veins of lower extremities. PLoS One. 2022;17(5):e0268725.
  • Ahmed WU, Kleeman S, Ng M, Wang W, Auton A, 23andMe Research Team. Lee R, Handa A, Zondervan KT, Wiberg A, Furniss D. Genome-wide association analysis and replication in 810,625 individuals with varicose veins. Nat Commun. 2022 Jun 02;13(1):3065.
  • sabel C. Valencia, MD, Anna Falabella, MD, Robert S. Kirsner, MD, and William H. Eaglstein, MD Miami, Florida Chronic venous insufficiency and venous leg ulceration J AM ACAD DERMATOL MARCH 2001
  • Minhaj Ahmad1 and Abdul Nasir2 * MANAGEMENT OF VENOUS LEG ULCER THROUGH UNANI MEDICINE ALONG WITH LEECH THERAPY-A CASE STUDY World Journal of Pharmaceutical Research SJIF Impact Factor 8.074 Volume 7, Issue 14, 836-844. ol, 2018
  • zarnigar, md. anwar alam Clinical Efficacy of Leech Therapy In Varicose Ulcer-A Case Series tahaffuzi wa samaji tib (psm), nium, Bangalore Phcog.Net | www.unanires.org Jan 2011 | Vol 1 | Issue 1
  • Mir RA, Nayab M, Mir UY, Ansari AN. Preventive and Therapeutic values of Leech Therapy: A Review. Journal of Drug Delivery and Therapeutics. 2024 Aug 15;14(8):183-9.
  • Baglioni EA, Perego F, Paolin E, Abate A, Pusceddu T, Zavan B, Bocchiotti MA. Efficacy of autologous micrografts technology: a promising approach for chronic wound healing and tissue regeneration—a pilot study. Frontiers in Medicine. 2024 Jul 26;11:1417920.
  • Srinidhi R, Raveenthiran V. Tropical Phagedenic Ulcer. ( venous ulcer studies )
  • (Giamberardino, M. A. (Ed.). (2009). Visceral pain: clinical, pathophysiological and therapeutic aspects. Oxford University Press.).
  • Rajput H. Basic Imperative Leech Therapy.
  • Marchiori CH, de Oliveira Santana MV, de Paula Malheiros K. Leeches and Their Use in Medicine (Annellida: Hirudinea: Rhynchobdelliformes).