Objective To evaluate the therapeutic effects and safety of Kangfuxin Solution（康复新液） on chronic skin ulcer. Methods A total of 176 patients with chronic skin ulcer were randomly divided into an external application group（external application of Kangfuxin Solution） of 59 cases

an oral administration and external application group（oral administration and external application of Kangfuxin Solution） of 59 cases

a basic fibroblast growth factor（bFGF） group（external application） of 58 cases. All groups received conventional debridement

and wound area was applied hydropathic compress or external spray of Kangfuxin Solution or b FGF. The wounds were dressed with sterile gauze

and dressings were changed once a day

with 4 weeks as a treatment course. The oral administration and external application group was given oral administration of Kangfuxin Solution

10 ml each time

3 times a day.All groups were treated for 4 weeks. The ulcer area

depth

color

exudate and granulation tissue score before and after treatment were observed to evaluate the clinical efficacy

and the adverse actions were observed. Results The ulcer area

depth

color score

exudate scores were significantly reduced after treatment（P < 0. 05）

and granulation score was increased significantly（P < 0. 05）. After treatment

the average wound area and color score in the oral administration and external application group were significantly reduced than the external application group and the bFGF group（P < 0. 05）. The total effective rate of the 3 groups was 94. 83%

96. 61% and 92. 98%

respectively.And there was no significant difference among groups（P > 0. 05）. Adverse events including pain

itching and allergy were not observed during the treatment. Conclusion The combination of oral use and external application of Kangfuxin Solution is effective and safe in treating chronic skin ulcer

which is better than external application alone in shortening the wound area and improving color

and without significant adverse effects.