Randomised Trial Results: dHAICM vs Standard Care in Diabetic Foot Ulcer Treatment

Randomised Trial Results: dHAICM vs Standard Care in Diabetic Foot Ulcer Treatment

Diabetic foot ulcers are a common and serious complication of diabetes, affecting up to 15–25% of patients during their lifetime. ¹ Despite conventional treatments like debridement, infection control, and offloading, there have been many instances where wounds have failed to heal in accordance with the expected healing pathway. Such a situation gives rise to a very significant question- can there be any method that goes beyond the standard treatment of wounds?

The answer could lie in a recent study that compared dehydrated Human Amnion – Intermediate Layer – Chorion Membrane Allograft (dHAICM) to standard treatment procedures for diabetic foot ulcers. And the results could mean great news to those looking for enhanced wound management.

Let’s explore more about this study and what it entails.

What Are Diabetic Foot Ulcers?

Diabetic Foot Ulcer (DFU) is defined as an open wound or lesion that occurs on the foot of someone with diabetes, especially at the plantar surface (bottom side) of the foot. These wounds are quite common in diabetics, and they affect about 15% of people who suffer from this disease. ²

Diabetic foot ulcers usually occur when there are several contributing factors, such as: ²

• Impaired blood flow
• Diabetic neuropathy
• Delayed wound healing

Why Are People With Diabetes More Susceptible to Foot Ulcers?

A diabetic foot ulcer is caused by a confluence of factors related to nerve damage, decreased blood flow, and problems with wound healing caused by diabetes. Chronically high levels of blood sugar in a patient’s body can lead to diabetic neuropathy, which causes nerve damage in the peripheral areas of the body. In such cases, feeling in the patient’s feet decreases, thus preventing early detection of any wounds.

In addition, diabetes leads to peripheral arterial disease, which decreases blood flow to the legs. The lack of oxygen and other elements, needed for healthy tissues, makes it harder for the skin to heal itself properly after any inflicted damages.

Patients with diabetes have impaired immunity, thus making them vulnerable to infections and decreasing their ability to cope with them. ³

Why Are Diabetic Wounds Harder to Heal?

People with diabetes usually have poor wound healing due to the presence of high levels of glucose in the body. This is because high levels of glucose affect various processes that contribute to wound healing such as the functioning of white blood cells, whose job is to protect the body against infections and inflammation.

Diabetes leads to damage of blood vessels, leading to poor flow of oxygen, nutrients, and other substances necessary for proper healing of injuries. Moreover, patients suffering from diabetes have impaired angiogenesis, collagen production, low fibroblast activity, as well as poor cell migration, resulting in poor development of new tissues.

Together, these factors create a compromised healing environment where wounds heal more slowly and are more likely to become chronic, non-healing ulcers. ³

Bridging The Gap in DFU Treatment

The current standard treatment for diabetic foot ulcers typically includes: ²

• Cleaning and removing dead tissue (debridement)
• Reducing pressure on the wound (offloading)
• Managing infection
• Maintaining proper moisture balance

While these approaches are essential for wound management, they primarily focus on controlling the wound rather than actively repairing it.

As a result, many diabetic foot ulcers remain slow to heal or do not heal completely, especially in patients with poor circulation, nerve damage, or long-standing diabetes. This highlights a key limitation that standard treatment may not always fully address. Like underlying biological challenges in some patients, such as reduced blood supply, persistent inflammation, impaired cell activity and tissue regeneration.

The Need for Advanced Therapies

To overcome these limitations, there is a growing need for therapies that go beyond basic wound care and actively support the healing process. This is where allografts play an important role.

Allografts, especially those made from human placental tissue, are intended to help create a supportive environment for healing. Instead of just covering the wound, they may support aspects of the tissue repair process. Because of this, allografts are especially helpful in chronic or non-healing diabetic foot ulcers, where regular treatment may not be enough.

This shift towards better, more supportive treatments has led to advanced options like dHAICM, which are now being studied for their effectiveness in improving healing outcomes. ¹

About The Clinical Study

To understand how effective advanced treatments like dHAICM can be, a recent clinical study looked at its role in healing non-healing diabetic foot ulcers. ²

It was a randomized, multi-center clinical trial (ELITE & CAMPLIFE) involving two groups of patients:

• The first group was given standard treatment only
• The second group received the dHAICM plus standard therapy

The following factors were considered in the research:

• Reduction of the wound size
• Complete wound healing
• Speed of healing process

How dHAICM Work?

dHAICM is made from human placental tissue and works by supporting the body’s natural healing process. It contains a combination of growth factors, proteins, and structural components that aid in better wound management.

Here’s how it helps:

• Provides a natural support layer (scaffold)
• Boosts healing signals
• Improves blood supply (angiogenesis)
• Reduces inflammation
• Supports overall healing process

In simple terms, instead of just covering the wound, dHAICM creates the ideal environment for the body to repair the skin more efficiently. ⁴

Key Clinical Results of dHAICM in DFU Treatment

The interim results from the clinical trials showed clear improvements when dHAICM was used along with standard care.

An approximate 78% reduction in wound area was observed in the dHAICM group compared to about 38% in the standard care group, based on interim analysis.

Clinical Benefits for Healthcare Providers

Here are some clinical benefits:

• Provides important growth factors which play a role in enhancing the body’s own healing processes, thus aiding better wound care
• Helps in the regulation of inflammation, thereby maintaining the right conditions for healing
• Encourages cellular reactions like migration of cells and formation of new blood vessels
• Functions as a biological matrix, encouraging cells to attach to it for support
• Helps enhance patient comfort by aiding pain relief
• Facilitates efficient wound management, which helps minimize complications
• Simple to integrate into clinical practice and does not disrupt routine practices
• Aids efficient wound management in diabetic foot ulcers. ⁵

Final Thoughts

Wound management in diabetic patients can sometimes be quite tricky, and this is particularly true when conventional management fails to produce desirable results. In this respect, it is critical to evaluate possible new treatments that would make things easier for the clinician to manage.

Within the scope of our randomized controlled trial, we sought to determine how using dHAICM in conjunction with the existing therapy regimen would work to improve patient wound care outcomes. Insights from our research have proven that a physiological approach to healing is always much more beneficial.

As further research continues to prove the effectiveness of such techniques in practice, AmchoPlast™ can become a valuable addition to the clinician’s treatment approach when managing diabetic foot ulcers.