Critical limb ischemia (CLI) is clinically defined as relapsing pain at rest which lasts for more than two weeks and requires analgesic treatment with opiates; CLI is accompanied with ulceration or varied tissue loss and ankle systolic pressure lower than 50 mmHg or finger systolic pressure lower than 30 mmHg or transcutaneous partial oxygen tension under 30 mmHg.

The incidence of CLI is 500-1000 in a million people. Higher incidence is registered in diabetes patients, about 100.000 high amputations in EU countries and in the USA. From the point of view of an individual patient, the prognosis of CLI is relatively clearly defined. 25 % of patients die within one year, 30 % undergo amputation and 45 % survive with both lower limbs. Over 60 % of patients suffering from CLI die within 5 years.

A significant increase of not only diabetes patients has been registered in the last decade. This represents a serious global society problem because the number of people suffering from this disease is increasing every year and the number of severe complications which can result in permanent invalidity or death in an extreme case is increasing as well.

Lower limb critical ischemia is a very serious, life-threatening medical condition in diabetes patients. This disease is caused by worsened vessel supply of affected spot, vessel blockage and subsequently exsanguinating of lower limbs tissue with ankle or whole limb amputation risk. In diabetes patients it causes formation of chronical defects and wounds. Permanent limb loss is therefore a real threat to every diabetic with this diagnose.

This mostly accounts for diabetes patients over 50 years old in whom the doctors had exhausted all endovascular surgical treatment options and their leg is about to be amputated. These are patients who had been hospitalized for a long time, undergone catheterization procedures or have a bypass, very often they had lost their fingers or their limb partially and they have a lot of complications. They suffer from chronical pain, use drugs and often are bound to a wheelchair. It is not an exception when they live without a leg for a long time.

Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II).

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, TASC II

Working Group. J Vasc Surg. 2007 Jan; 45 Suppl S():S5-67.

 Infrainguinal revascularization because of claudication: total long-term outcome of endovascular and surgical treatment. Jämsén TS, Manninen HI, Tulla HE, Jaakkola PA, Matsi PJ, J Vasc Surg. 2003 Apr; 37(4):808-15.

The main cause of CLI is ischemia caused mostly by artery atherosclerosis, and possibly in combination with other risk factors (diabetes micro angiogenesis, peripheral diabetic polyneuropathy).


The main CLI development risk factors

  • Age > 50 + one of the atherosclerosis risk factors (smoking, dislipidemy, hypertension, diabetes mellitus)
  • Age > 70 regardless the risk factors
  • Clinical signs of lower limbs ischemic disease
  • Pain in lower limbs at effort
  • Pulse irregularities in lower limbs arteries when physically investigated
  • Other known indicators of atherosclerosis (coronary, carotid, renal)

Patients suitable for Angiocell – cell therapy treatment:

  • Chronical critical limb ischemy Rutherford 4-6, Fontaine III or IV
  • Exhausted options of basic conservative treatment and revascularization (bypass, angiosurgery)
  • Age above 18 years
  • Signed informed consent for the surgery
  • Without acute CLI complications requiring limb amputation