Clinical Trials


An analysis of case studies, articles and posters on use of amniotic membrane in chronical wounds treatment was the subject of the literal research. A set of 52 articles and 37 posters published in years 2000 to 2017 was chosen for given research.

A major share of the set is articles considering case studies focusing on the usage of amniotic membrane derivatives to support healing of chronic wounds.

Because of various characteristics of the research set, several parameters were chosen to be evaluated primarily in each individual article and poster. These parameters are the number of patients involved in the study and treated with amnion membrane derivatives; the number of patients evaluated in the study as successfully healed after the application of the treatment; the type of derivative used (dHAM – amniotic membrane derivative, dHACM – amniochorion membrane derivative, other derivatives – further specified); the number of applications of the derivative, or the frequency of applications (e.g. weekly/biweekly); the primary diagnosis requiring treatment; the location of application; the size of the wound (in cm2 ± standard deviation); and the time to complete healing in weeks (the average time to heal in case of multiple-patient studies).

The attached table shows the parameters described above. The entries of the individual articles and posters are not complete each time because of different structure of individual articles and the amount of given information about the progress of the study and treatment. In the articles in which the descriptive parameters set by us are not evident, is the topic of the article and also the reason why stated in the comment.

At the start, duplicated and missing sources were identified in the given research set. There are 3 duplicate articles [41, 42, 51] and one duplicate poster [36]. There is also one missing article [38] and one poster [10] in the numbered set.

GRAPH 1 Within the processed articles and case studies with known result of treatment, the set of 701 patients was covered from which 591 patients were successfully healed. It was 570 patients within the posters, 513 of which were successfully healed. From the obtained data it is evident that the effectiveness of the treatment is very high with its 84 % of effectiveness, or rather 90 %.

GRAPH 2 In the articles, there is numerical superiority of amniochorion membrane derivatives treatment over amniotic membrane treatment.

GRAPH 3 The sources also differ in the frequency of derivatives applications during the course of the treatment. Several articles also dealt with comparison of groups treated with derivatives applied each week and groups with the derivatives applied once in two weeks [1, 16]. These articles observed that weekly application of derivatives helped the healing process more; groups treated this way achieved shorter time of healing than the groups treated with applications once in 14 days. The research also shows that it is appropriate to apply the fresh derivatives, or to change the applied derivatives, several times in course of the treatment itself. Appropriately planned reapplication of derivatives can contribute to quicker healing of the wound. However the optimal amount of applications depends on the type of the wound, its size and healing progression, and it differs in each case.

Treatment with amniochorion membrane can be applied to a wide range of various injuries and diseases. One of the most common applications is the treatment of wounds caused by advanced stage of diabetes. Another typical application of derivatives is the treatment of venous ulcers on lower limbs and these diseases are also highly covered in the studies. The derivatives are also applied to treat postoperative chronic wounds and other injuries. They are also used in treatment of burns of all degrees [34]. An interesting use is in tympanoplasty where amniochorion derivative enabled the patient’s hearing to restore sooner [27]. It can also be used in dentistry [23] and ophthalmology [44]. An advantage is also easy preparation of the derivatives for wounds of different sizes. Application is not influenced by the size of given wound and therefore it can be used in healing small chronic wounds smaller than 1 cm2 as well as large wounds even larger than 100 cm2 [4]. As many studies confirmed, quicker healing is achieved in comparison with standard treatment.

The time of healing depends on individual parameters of each wound and it differs source to source; it does not exceed 10 weeks on average though. There are several articles in the processed set which were not possible to process with the list of established parameters. Several articles describing general use and characteristics of medical derivatives [19-23, 29-33] can be found in this group. Several articles describe the course of treatment of chronic wounds with derivatives, however the information in the articles are not supported by published data or they refer to other studies without stating necessary information [14, 17, 45-47, 52]. Several studies do not define the effectiveness of the treatment by healing of the wound but by other parameters, this fact makes their comparison to the rest of the set complicated [10-11, 49]. The quality of the treatment with placental derivatives is well illustrated with the number of more than one million derivative products distributed by company MiMedx [36].